Systems for protection of the cerebral vasculature during a cardiac procedure

ABSTRACT

Vascular filters and deflectors and methods for filtering bodily fluids. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 toU.S. Provisional Application Ser. No. 62/607,801, filed Dec. 19, 2017,the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

In general, the present disclosure relates to medical devices forfiltering blood. And, more particularly, in certain embodiments, to amethod and a system of filters and deflectors for protecting thecerebral arteries from emboli, debris and the like dislodged during anendovascular or cardiac procedure.

BACKGROUND

There are four arteries that carry oxygenated blood to the brain, i.e.,the right and left vertebral arteries, and the right and left commoncarotid arteries. Various procedures conducted on the human body, e.g.,transcatheter aortic valve replacement (TAVR), aortic valvevalvuloplasty, carotid artery stenting, closure of the left atrialappendage, mitral valve annuloplasty, repair or replacement, can causeand/or dislodge materials (whether native or foreign), these dislodgedbodies can travel into one or more of the cerebral arteries resultingin, inter alia, stroke. Moreover, atheromas along and within the aortaand aortic arch can be dislodged as the TAVR catheter is advanced towardthe diseased aortic valve and subsequently withdrawn after implantationis completed. In addition, pieces of the catheter itself can be strippedaway during delivery and implantation. These various forms of vasculardebris, whether native or foreign, can then travel into one or morecerebral arteries, embolize and cause, inter alia, a stroke or strokes.

There exist devices for protecting one or more cerebral arteries byeither collecting (filters) or deflecting (deflectors) debris. Singlefilters, such as those used during a carotid artery stenting are onesuch device.

Applicants have previously patented a dual filter embolic protectionsystem that protects the right vertebral, and right and left commoncarotid arteries, see e.g., U.S. Pat. No. 9,492,264, the entirety ofwhich is incorporated herein. Other attempts at deflecting debris fromentering one or more cerebral arteries using a deflector placed in theaorta or aortic arch have also been disclosed. Of the known medicaldevices, delivery systems, and methods, each has certain advantages anddisadvantages. There is an ongoing need to provide alternative medicaldevices and methods as well as alternative methods for manufacturing andusing medical devices.

SUMMARY

Certain aspects of the present disclosure address debris, tissue, etc.,that can be dislodged during an endovascular procedure, this debris cantravel toward, into and embolize within the cerebral vasculature leadingto stroke or ischemia in an artery occluded, partially or totally, bythe clot. For example, during a transcatheter aortic valve replacement(TAVR), stenotic material around the valve can be dislodged duringimplantation of the artificial valve. Moreover, atheroma along andwithin the aorta and aortic arch can be dislodged as the TAVR catheteris advanced toward the diseased aortic valve and subsequently withdrawnafter implantation is completed. In addition, pieces of the catheteritself can be stripped away during delivery and implantation. Thesevarious forms of vascular debris, whether native or foreign, can thentravel into one or more cerebral arteries, embolize and cause a stroke,strokes or neurocognitive deficits, for example.

Certain aspects of the present disclosure are intended to address thesepotentially devastating cerebral events by providing a delivery systemcomprised of filters and/or deflectors and/or combinations thereof, tointercept this debris before it can enter any of the cerebral arteries.

Certain aspects of the present disclosure, and its various embodiments,can provide a compound system of filters and/or deflectors forcollecting (and/or deflecting) debris in a manner such that all fourcerebral arteries are protected.

Vascular filters and deflectors and methods for filtering bodily fluidsare disclosed herein. A blood filtering assembly can capture embolicmaterial dislodged or generated during an endovascular procedure toinhibit or prevent the material from entering the cerebral vasculature.A blood deflecting assembly can deflect embolic material dislodged orgenerated during an endovascular procedure to inhibit or prevent thematerial from entering the cerebral vasculature.

In a first example, a method of inhibiting embolic material fromentering cerebral vasculature may comprise positioning a guidewirethrough a right subclavian artery and into a left common carotid arteryand tracking a distal portion of a first protection device over theguidewire. The distal portion of the first protection device maycomprise a proximal sheath, a proximal self-expanding filter assemblyradially within the proximal sheath, a distal sheath, and a distalself-expanding filter assembly radially within the distal sheath. Themethod may further comprise at least one of proximally retracting theproximal sheath and distally advancing the proximal self-expandingfilter assembly to deploy the proximal self-expanding filter assemblyfrom the proximal sheath in the innominate artery, steering the distalsheath into a left common carotid artery, at least one of proximallyretracting the distal sheath and distally advancing the distalself-expanding filter assembly to deploy the distal self-expandingfilter assembly from the distal sheath in the left common carotidartery, after deploying the proximal and distal self-expanding filterassemblies, withdrawing the proximal and distal sheaths, and tracking adistal portion of a second protection device from an incision in afemoral artery to an aortic arch. The distal portion of the secondprotection device may comprise an outer sheath, an inner tubular memberradially within the outer sheath, and a self-expanding filter assemblyradially within the outer sheath and coupled to the inner tubularmember. The method may further comprise at least one of least one ofproximally retracting the outer sheath and distally advancing the innertubular member to deploy the self-expanding filter assembly from theouter sheath.

Alternatively or additionally to any of the examples above, in anotherexample, an opening of the self-expanding filter assembly of the secondprotection device may be positioned in the aortic arch upstream of anostium of a left subclavian artery.

Alternatively or additionally to any of the examples above, in anotherexample, the opening may be a distally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the second protection device may further comprise a pigtailcatheter radially inward of the inner tubular member.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise after deploying self-expandingfilter assembly of the second protection device, withdrawing the pigtailcatheter.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise performing an endovascularprocedure, the deployed proximal and distal filter assemblies of thefirst protection device and the self-expanding filter assembly of thesecond protection device inhibiting embolic material from enteringcerebral vasculature through the left vertebral artery, a right commoncarotid artery, a right vertebral artery and the left common carotidartery during the endovascular procedure.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise after performing theendovascular procedure, withdrawing the proximal and distal filterassemblies of the first protection device and the self-expanding filterassembly of the second protection device.

Alternatively or additionally to any of the examples above, in anotherexample, a procedural catheter for performing the endovascular proceduremay be advanced through a lumen of the inner tubular member of thesecond protection device.

Alternatively or additionally to any of the examples above, in anotherexample, an opening of the self-expanding filter assembly of the secondprotection device may be positioned in a left subclavian artery upstreamof an ostium of a left vertebral artery.

Alternatively or additionally to any of the examples above, in anotherexample, the opening may be a proximally facing opening.

In another example, a method of inhibiting embolic material fromentering cerebral vasculature may comprise positioning a first guidewirethrough a right subclavian artery and into a left common carotid arteryand tracking a distal portion of a first protection device over theguidewire. The distal portion of the first protection device maycomprise a proximal sheath, a proximal self-expanding filter assemblyradially within the proximal sheath, a distal sheath, and a distalself-expanding filter assembly radially within the distal sheath. Themethod may further comprise at least one of proximally retracting theproximal sheath and distally advancing the proximal self-expandingfilter assembly to deploy the proximal self-expanding filter assemblyfrom the proximal sheath in the innominate artery, steering the distalsheath into a left common carotid artery, at least one of proximallyretracting the distal sheath and distally advancing the distalself-expanding filter assembly to deploy the distal self-expandingfilter assembly from the distal sheath in the left common carotidartery, after deploying the proximal and distal self-expanding filterassemblies, withdrawing the proximal and distal sheaths, positioning asecond guidewire through a femoral artery and into a left subclavianartery, and tracking a distal portion of a second protection device overthe second guidewire. The distal portion of the second protection devicemay comprise an outer sheath, a catheter shaft radially within the outersheath, and an inflatable balloon radially within the outer sheath andcoupled to the catheter shaft. The method may further comprise at leastone of least one of proximally retracting the outer sheath and distallyadvancing the catheter shaft to deploy the inflatable balloon from theouter sheath in the left subclavian artery and inflating the inflatableballoon.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise performing an endovascularprocedure, the deployed proximal and distal filter assemblies andinflatable balloon inhibiting embolic material from entering cerebralvasculature through the left vertebral artery, a right common carotidartery, a right vertebral artery and the left common carotid arteryduring the endovascular procedure.

Alternatively or additionally to any of the examples above, in anotherexample, the method may further comprise after performing theendovascular procedure, withdrawing the proximal and distal filterassemblies and the inflatable balloon.

Alternatively or additionally to any of the examples above, in anotherexample, a procedural catheter for performing the endovascular proceduremay be advanced through a lumen of the outer sheath of the secondprotection device.

In another example, an embolic protection system for isolating thecerebral vasculature may comprise a first protection device having aproximal portion configured to remain outside the body and a distalportion. The distal portion of the first protection device may comprisea proximal sheath, a proximal self-expanding filter assembly radiallywithin the proximal sheath, a distal sheath, and a distal self-expandingfilter assembly radially within the distal sheath. The system mayfurther comprise a second protection device having a proximal portionconfigured to remain outside the body and a distal portion. The distalportion of the second protection device may comprise an outer sheath, aninner tubular member radially within the outer sheath, a self-expandingfilter assembly radially within the outer sheath and coupled to theinner tubular member, and a pigtail catheter radially within the outersheath.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal self-expanding filter assembly may include adistally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the distal self-expanding filter assembly may include aproximally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the self-expanding filter assembly of the second protectiondevice may include a distally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the self-expanding filter assembly of the second protectiondevice may include a proximally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the pigtail catheter may be radially within the self-expandingfilter assembly of the second protection device.

In another example, an embolic protection system for isolating thecerebral vasculature may comprise a first protection device having aproximal portion configured to remain outside the body and a distalportion. The distal portion of the first protection device may comprisea proximal sheath, a proximal self-expanding filter assembly radiallywithin the proximal sheath, a distal sheath, and a distal self-expandingfilter assembly radially within the distal sheath. The system mayfurther comprise a second protection device having a proximal portionconfigured to remain outside the body and a distal portion. The distalportion of the second protection device may comprise an outer sheath, aninner tubular member radially within the outer sheath, a mechanismconfigured to occlude a flow of particulates, the mechanism within theouter sheath and coupled to the inner tubular member, and a pigtailcatheter radially within the outer sheath.

Alternatively or additionally to any of the examples above, in anotherexample, the mechanism may comprise a self-expanding filter assembly.

Alternatively or additionally to any of the examples above, in anotherexample, the self-expanding filter assembly of the second protectiondevice may include a distally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the self-expanding filter assembly of the second protectiondevice may include a proximally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the mechanism may comprise an inflatable balloon.

Alternatively or additionally to any of the examples above, in anotherexample, the pigtail catheter may be radially within the inner tubularmember.

Alternatively or additionally to any of the examples above, in anotherexample, the system may further comprise a filter wire coupled to theself-expanding filter assembly of the second protection device.

Alternatively or additionally to any of the examples above, in anotherexample, each of the proximal self-expanding filter, the distalself-expanding filter, and the mechanism may be configured to beindividually deployed.

Alternatively or additionally to any of the examples above, in anotherexample, at least one of the first or second protection devices may beconnected to an arterial pressure monitoring device.

Alternatively or additionally to any of the examples above, in anotherexample, the inner tubular member may comprise a guidewire lumen.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal sheath may be articulatable.

Alternatively or additionally to any of the examples above, in anotherexample, the distal sheath may be articulatable.

Alternatively or additionally to any of the examples above, in anotherexample, the outer sheath may be articulatable.

Alternatively or additionally to any of the examples above, in anotherexample, the proximal self-expanding filter assembly may include adistally facing opening.

Alternatively or additionally to any of the examples above, in anotherexample, the distal self-expanding filter assembly may include aproximally facing opening.

The above summary of exemplary embodiments is not intended to describeeach disclosed embodiment or every implementation of the presentdisclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIGS. 1A and 1B illustrate a first embodiment for deploying threefilters to protect the cerebral vascular architecture.

FIG. 1C illustrates an alternate embodiment of the three filter systemof FIGS. 1A and 1B.

FIG. 1D illustrates an alternate embodiment of the three filter systemof FIGS. 1A and 1B.

FIG. 2 illustrates another embodiment of a three filter system.

FIG. 3 illustrates a single filter system including a deflector.

FIG. 4 illustrates a dual filter system including a deflector.

FIG. 5 illustrates another embodiment of a three filter system.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit aspects of the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the invention. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

The currently marketed Sentinel system made by Claret Medical andembodiments of which are described in U.S. Pat. No. 9,492,264 mentionedabove has two filters, a first which protects the right brachiocephalicartery, from which the right vertebral and right common carotid arteriestypically originate, and a second filter in the left common carotidartery. In a typical patient, the left vertebral artery which providesapproximately seven percent of the perfusion to the brain is leftunprotected.

One disclosed solution to protecting the left vertebral is the use of asecond device intended to be placed in the left arm, e.g. through theleft radial artery, with a filter placed in the left subclavian fromwhich the left vertebral typically originates. Embodiments of such asolution can be found in U.S. Pat. No. 9,566,144, the entirety of whichis hereby incorporated by reference herein.

The present application discloses several multi-vessel embodiments whichmay include compound systems of filters and/or deflectors that canprovide full cerebral protection.

The disclosure generally relates to devices and methods for filteringfluids and/or deflecting debris contained within fluids, including bodyfluids such as blood. A filtering or deflecting device can be positionedin an artery before and/or during an endovascular procedure (e.g.,transcatheter aortic valve implantation (TAVI) or replacement (TAVR),transcatheter mitral valve implantation (TAMI) or replacement (TAMR),surgical aortic valve replacement (SAVR), other surgical valve repair,implantation, or replacement, cardiac ablation (e.g., ablation of thepulmonary vein to treat atrial fibrillation) using a variety of energymodalities (e.g., radio frequency (RF), energy, cryo, microwave,ultrasound), cardiac bypass surgery (e.g., open-heart, percutaneous),transthoracic graft placement around the aortic arch, valvuloplasty,etc.) to inhibit or prevent embolic material such as debris, emboli,thrombi, etc. resulting from entering the cerebral vasculature.

The devices may be used to trap and/or deflect particles in other bloodvessels within a subject, and they can also be used outside of thevasculature. The devices described herein are generally adapted to bedelivered percutaneously to a target location within a subject, but canbe delivered in any suitable way and need not be limited tominimally-invasive procedures.

FIG. 1A is a schematic view of an aortic arch 10 including a firstprotection device 30. The aortic arch 10 is upstream of the left andright coronary arteries (not explicitly shown). The aortic arch 10typically includes three great branch arteries: the brachiocephalicartery or innominate artery 12, the left common carotid artery 14, andthe left subclavian artery 16. The innominate artery 12 branches to theright carotid artery 18, then the right vertebral artery 20, andthereafter is the right subclavian artery 22. The right subclavianartery 22 supplies blood to, and may be directly accessed from (termedright radial access), the right arm. The left subclavian artery 16branches to the left vertebral artery 24, usually in the shoulder area.The left subclavian artery 16 supplies blood to, and may be directlyaccessed from (termed left radial axis), the left arm. Four of thearteries illustrated in FIG. 1A supply blood to the cerebralvasculature: (1) the left carotid artery 14 (about 40% of cerebral bloodsupply); (2) the right carotid artery 18 (about 40% of cerebral bloodsupply); (3) the right vertebral artery 20 (about 10% of cerebral bloodsupply); and (4) the left vertebral artery 24 (about 10% of cerebralblood supply).

It may be desirable to filter blood flow to all four arteries 14, 18,20, 24 supplying blood to the brain and/or deflect particulates fromentering the arteries 14, 18, 20, 24 supplying the brain. It may also bedesirable to limit the number of incision sites or cuts required todeploy the system(s). FIG. 1A illustrates a first step in deploying amulti-filter system using a right radial access incision.

The first protection device 30 may include a distal end region 32 and aproximal end region 38. The proximal end region 38 may be configured tobe held and manipulated by a user such as a surgeon. The distal endregion 32 may be configured to be positioned at a target location suchas, but not limited to, the innominate artery 12 and/or the left commoncarotid artery 14. When the distal end region 32 is so deployed, bloodis filtered prior to entering the left common carotid artery 14, theright common carotid artery 18, and the right vertebral artery 20.

The proximal end region 38 may include a handle 40, a control 42 such asa slider, an outer sheath 44, a port 46, an inner member translationcontrol 48 such as a knob, and hemostasis valve control 50 such as aknob. In some embodiments, the handle 40 may include fewer or morecontrol elements than those illustrated in FIG. 1A. The proximal endregion may also include an inner member 52 radially inward of the outersheath 44. While not explicitly shown, the proximal end region 38 mayalso include a filter wire 66 radially inward of the outer sheath 44(and sometimes radially outward of the inner member 52). Someillustrative filter wires are described in commonly assigned U.S. Pat.No. 9,566,144, the entirety of which is hereby incorporated byreference.

The slider 42 can be used to translate the outer sheath 44 and/or afilter assembly 36 (e.g., coupled to a proximal shaft 54). For example,the slider 42 may proximally retract the outer sheath 44, the slider 42may distally advance the filter assembly 36 out of the outer sheath 44,or the slider 42 may proximally retract the outer sheath 44 and distallyadvance the proximal filter assembly 36 (e.g., simultaneously orserially), which can allow the proximal filter assembly 36 to radiallyexpand. The slider 42 may also be configured to have an oppositetranslation effect, which can allow the filter assembly 36 to beradially collapsed (e.g., due to compression by the outer sheath 44) asthe filter assembly 36 is drawn into the outer sheath 44. Otherdeployment systems are also possible, for example comprising gears orother features such as helical tracks (e.g., configured to compensatefor any differential lengthening due to foreshortening of the filterassembly 36, configured to convert rotational motion into longitudinalmotion), a mechanical element, a pneumatic element, a hydraulic element,etc. for opening and/or closing the filter assembly 36. While notexplicitly shown, the handle 40 may include a similar mechanism formanipulating the distal filter assembly 34 via the filter wire 66, theinner member 52 and/or the guiding member 60.

The port 46 is in fluid communication with the inner member 52 (e.g.,via a Y-shaped connector in the handle 40). The port 46 can be used toflush the device (e.g., with saline) before, during, and/or after use,for example to remove air. The port 46 can additionally, oralternatively, be used to monitor blood pressure at the target location,for example by connecting an arterial pressure monitoring device influid communication with a lumen of the outer sheath 44. The port 46 canbe also or alternatively be used to inject contrast agent, dye,thrombolytic agents such as tissue plasminogen activator (t-PA), etc.The slider 42 may be independent of the inner member 52 such that theinner member 52 is longitudinally movable independent of the proximalfilter assembly 36 and the outer sheath 44 (and/or the distal filterassembly 34, the filter wire 66, inner member 52, or the guiding member60). The inner member translation control 48 can be used tolongitudinally translate the inner member 52, for example before, after,and/or during deployment of the filter assembly 36. The inner membertranslation control 48 may comprise a slider in the handle 40 (e.g.,separate from the slider 42).

The rotatable hemostasis valve control 50 can be used to reduce orminimize fluid loss through the protection device 30 during use. Forexample, a proximal portion and/or intermediate region of the protectiondevice may be positioned in the right subclavian artery 22 and thedirection of blood flow with respect to the device 30 will be distal toproximal, so blood may be otherwise inclined to follow the pressure dropout of the device 30. The hemostasis valve control 50 is illustrated asbeing rotatable, but other arrangements are also possible (e.g.,longitudinally displaceable). The hemostasis valve control 50 may beconfigured to fix relative positions of the outer sheath 44 and thefilter assembly 36, for example as described with respect to thehemostasis valve in U.S. Pat. No. 8,876,796. The hemostasis valve 50 maycomprise, for example, an elastomeric seal and HV nut.

The distal end region 32 may include a first or distal filter assembly34 configured to be deployed within the left common carotid artery 14and a second or proximal filter assembly 36 configured to deployedwithin the innominate artery 12. The distal end region 32 may furtherinclude a proximal (or outer) sheath 44, a proximal shaft 54 coupled toan expandable proximal filter assembly 36, a distal shaft 56 coupled toa distal articulatable sheath 58, a distal filter assembly 34, andguiding member 60.

The proximal shaft 54 is co-axial with proximal sheath 44, and aproximal region 62 of proximal filter assembly 36 is secured to proximalshaft 54. In its collapsed configuration (not explicitly shown), theproximal filter assembly 36 may be disposed within proximal sheath 44and is disposed distally relative to proximal shaft 54. The proximalsheath 44 may be axially (e.g., distally and proximally) movablerelative to proximal shaft 54 and the proximal filter assembly 36. Thesystem 30 may also include a distal sheath 58 secured to a distal regionof the distal shaft 56. The distal shaft 56 may be co-axial with theproximal shaft 54 and the proximal sheath 44. The distal sheath 58 anddistal shaft 56 may be secured to one another and axially movablerelative to the proximal sheath 44, the proximal shaft 54, and theproximal filter assembly 36. The system 30 may also include a distalfilter assembly 34 carried by the guiding member 60. While notexplicitly shown, the distal filter assembly 34 may be maintained in acollapsed configuration within the distal sheath 58. The guiding member60 may be coaxial with distal sheath 58 and distal shaft 56 as well asproximal sheath 44 and proximal shaft 54. The guiding member 60 may beaxially movable relative to distal sheath 58 and distal shaft 56 as wellas proximal sheath 44 and proximal shaft 54. The proximal sheath 44, thedistal sheath 58, and the guiding member 60 may each be adapted to beindependently moved axially relative to one other. That is, the proximalsheath 44, the distal sheath 58, and the guiding member 60 are adaptedfor independent axial translation relative to each of the other twocomponents. It is contemplated that the handle 40 may include controlelements (such as, but not limited to, slides, switches, buttons, dials,etc.) configured to individually actuate the proximal sheath 44, thedistal sheath 58, and the guiding member 60.

The proximal filter assembly 36 may include a support element or frame35 and a filter element 37. Similarly, the distal filter assembly 34includes support element 31 and a filter element 33. The frames 31, 35may generally provide expansion support to the filter elements 33, 37 inthe expanded state. In the expanded state, the filter elements 33, 37are configured to filter fluid (e.g., blood) flowing through the filterelements 33, 37 and to inhibit or prevent particles (e.g., embolicmaterial) from flowing through the filter elements 33, 37 by capturingthe particles in the filter elements 33, 37. The frames 31, 35 areconfigured to engage or appose the inner walls of a lumen (e.g., bloodvessel) in which the filter assembly 34, 36 is expanded. The frames 31,35 may comprise or be constructed of, for example, nickel titanium(e.g., nitinol), nickel titanium niobium, chromium cobalt (e.g., MP35N,35NLT), copper aluminum nickel, iron manganese silicon, silver cadmium,gold cadmium, copper tin, copper zinc, copper zinc silicon, copper zincaluminum, copper zinc tin, iron platinum, manganese copper, platinumalloys, cobalt nickel aluminum, cobalt nickel gallium, nickel irongallium, titanium palladium, nickel manganese gallium, stainless steel,combinations thereof, and the like. The frames 31, 35 may comprise awire (e.g., having a round (e.g., circular, elliptical) or polygonal(e.g., square, rectangular) cross-section). For example, in someembodiments, the frames 31, 35 comprises a straight piece of nitinolwire shape set into a circular or oblong hoop or hoop with one or twostraight legs running longitudinally along or at an angle to alongitudinal axis of the filter assembly 34, 36. At least one of thestraight legs may be coupled to a filter wire 66 or a strut 64, as shownwith respect to the distal filter assembly 34. The straight legs may beon a long side of the filter assembly 34, 36 and/or on a short side ofthe filter assembly 34, 36. The frames 31, 35 may form a shape of anopening 39, 41 of the filter assembly 34, 36. The opening 39, 41 may becircular, elliptical, or any shape that can appropriately apposesidewalls of a vessel such as the left subclavian artery or the leftvertebral artery. The filter assembly 34, 36 may have a generallyproximally-facing opening 39, 41. In other embodiments, the opening 39,41 may be distally facing. The orientation of the opening 39, 41 mayvary depending on where the access incision is located. For example, asshown in FIG. 1A, the proximal filter assembly 36 has a generallydistally-facing opening 41, and the distal filter assembly 34 has agenerally proximally-facing opening 39 relative to the device 30. Thefilter assemblies 34, 36 can be thought of as facing oppositedirections.

The frames 31, 35 may include a radiopaque marker such as a small coilwrapped around or coupled to the hoop to aid in visualization underfluoroscopy. In some embodiments, the frame may comprise a shape otherthan a hoop, for example, a spiral. In some embodiments, the filterassembly 34, 36 may not include or be substantially free of a frame.

In some embodiments, the frames 31, 35 and the filter elements 33, 37form an oblique truncated cone having a non-uniform or unequal lengtharound and along the length of the filter assembly 34, 36. In such aconfiguration, along the lines of a windsock, the filter assembly 34, 36has a larger opening 39, 41 (upstream) diameter and a reduced ending(downstream) diameter.

The filter elements 33, 37 may include pores configured to allow bloodto flow through the filter elements 33, 37, but that are small enough toinhibit prevent particles such as embolic material from passing throughthe filter elements 33, 37. The filter elements 33, 37 may comprise afilter membrane such as a polymer (e.g., polyurethane,polytetrafluoroethylene (PTFE)) film mounted to the frame 31, 35. Thefilter element may have a thickness between about 0.0001 inches andabout 0.03 inches (e.g., no more than about 0.0001 inches, about 0.001inches, about 0.005 inches, about 0.01 inches, about 0.015 inches, about0.02 inches, about 0.025 inches, about 0.03 inches, ranges between suchvalues, etc.).

The film may comprise a plurality of pores or holes or aperturesextending through the film. The film may be formed by weaving orbraiding filaments or membranes and the pores may be spaces between thefilaments or membranes. The filaments or membranes may comprise the samematerial or may include other materials (e.g., polymers, non-polymermaterials such as metal, alloys such as nitinol, stainless steel, etc.).The pores of the filter elements 33, 37 are configured to allow fluid(e.g., blood) to pass through the filter elements 33, 37 and to resistthe passage of embolic material that is carried by the fluid. The porescan be circular, elliptical, square, triangular, or other geometricshapes. Certain shapes such as an equilateral triangular, squares, andslots may provide geometric advantage, for example restricting a partlarger than an inscribed circle but providing an area for fluid flownearly twice as large, making the shape more efficient in filtrationverses fluid volume. The pores may be laser drilled into or through thefilter elements 33, 37, although other methods are also possible (e.g.,piercing with microneedles, loose braiding or weaving). The pores mayhave a lateral dimension (e.g., diameter) between about 10 micron (μm)and about 1 mm (e.g., no more than about 10 μm, about 50 μm, about 100μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 400μm, about 500 μm, about 750 μm, about 1 mm, ranges between such values,etc.). Other pore sizes are also possible, for example depending on thedesired minimum size of material to be captured.

The material of the filter elements 33, 37 may comprise a smooth and/ortextured surface that is folded or contracted into the delivery state bytension or compression into a lumen. A reinforcement fabric may be addedto or embedded in the filter elements 33, 37 to accommodate stressesplaced on the filter elements 33, 37 during compression. A reinforcementfabric may reduce the stretching that may occur during deployment and/orretraction of the filter assembly 34, 36. The embedded fabric maypromote a folding of the filter to facilitate capture of embolic debrisand enable recapture of an elastomeric membrane. The reinforcementmaterial could comprise, for example, a polymer and/or metal weave toadd localized strength. The reinforcement material could be imbeddedinto the filter elements 33, 37 to reduce thickness. For example,imbedded reinforcement material could comprise a polyester weave mountedto a portion of the filter elements 33, 37 near the longitudinalelements of the frames 31, 35 where tensile forces act upon the frames31, 35 and filter elements 33, 37 during deployment and retraction ofthe filter assembly 34, 36 from the outer sheath 44 and/or the distalsheath 58.

In some cases, the filter assembly 34, 36 may include a self-expandingfilter assembly (e.g., comprising a superelastic material withstress-induced martensite due to confinement in the outer sheath 44and/or the distal sheath 58). The filter assembly 34, 36 may comprise ashape-memory material configured to self-expand upon a temperaturechange (e.g., heating to body temperature). The filter assembly 34, 36may comprise a shape-memory or superelastic frame (e.g., comprising adistal end hoop comprising nitinol) and a microporous material (e.g.,comprising a polymer including laser-drilled holes) coupled to theframe, for example similar to the filter assemblies described in U.S.Pat. No. 8,876,796.

The filter assembly 34, 36 may be coupled (e.g., crimped, welded,soldered, etc.) to a distal end of a deployment wire or filter wire 66via a strut or wire 64, although this is not required. When both or allof the filter wire 66 and the strut 64 are provided, the filter wire 66and the strut 64 may be coupled within the guiding member 60 proximal tothe filter assembly 34 using a crimp mechanism. In other embodiments,the filter wire 66 and the strut 64 may be a single unitary structure.The filter wire 66 and/or strut 64 can comprise a rectangular ribbon, around (e.g., circular, elliptical) filament, a portion of a hypotube, abraided structure (e.g., as described herein), combinations thereof, andthe like. The filter wire 66 can be coupled to the handle 40 and/or aslider to provide differential longitudinal movement versus the outersheath 44, as shown by the arrows 68, which can sheathe and unsheathethe distal filter assembly 34 from the distal sheath 58. Similarly, theproximal filter assembly 36 may be unsheathe through actuation of amechanism on the handle 40 or through movement of the handle 40 itself.

The filter assembly 34, 36 in an expanded, unconstrained state has amaximum diameter or effective diameter (e.g., if the mouth is in theshape of an ellipse) d1, d2. The diameter d1, d2 can be between about 1mm and about 15 mm (e.g., at least about 1 mm, about 2 mm, about 3 mm,about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about15 mm, ranges between such values, etc.). In some embodiments, thediameter d1, d2 is between about 7 mm and about 12 mm (e.g., about 7 mm,about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, rangesbetween such values, etc.). In some embodiments, the diameter d isbetween about 2 mm and about 4.5 mm (e.g., about 2 mm, about 2.5 mm,about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, ranges between suchvalues, etc.). Other diameters d1, d2 or other types of lateraldimensions are also possible. Different diameters d1, d2 can allowtreatment of a selection of subjects having different vessel sizes.

The filter assembly 34, 36 has a maximum length L1, L2. The length L1,L2 can be between about 7 mm and about 50 mm (e.g., at least about 7 mm,about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm,about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about24 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm,about 50 mm, ranges between such values, etc.). Other lengths L1, L2 arealso possible, for example based on the diameter or effective diameterd1, d2. For example, the length L1, L2 of the filter assembly 34, 36 mayincrease as the diameter d1, d2 increases, and the length L1, L2 of thefilter assembly 34, 36 may decrease as the diameter d1, d2 decreases. Adistance from an apex of the mouth of the filter assembly 34, 36 to anelbow in the frame may be about 35 mm. Different lengths L1, L2 canallow treatment of a selection of subjects having different vesselsizes.

As described in more detail below, the distal sheath 58 may be adaptedto be steered, or bent, relative to the proximal sheath 44 and theproximal filter assembly 36. As the distal sheath 58 is steered, therelative directions in which the openings face will be adjusted.Regardless of the degree to which the distal sheath 58 is steered, thefilter assemblies 34, 36 are still considered to having openings facingopposite directions. For example, the distal sheath 58 could be steeredto have an approximately 180 degree bend, in which case the filterassemblies 34, 36 would have openings 39, 41 facing in substantially thesame direction, as shown in FIG. 1B. The directions of the filteropenings 41, 39 are therefore described if the system were to assume asubstantially straightened configuration (not explicitly shown). Theproximal filter element 37 may taper down in the proximal direction fromsupport element 35, while the distal filter element 33 may taper down inthe distal direction from support element 31. A fluid, such as blood,flows through the opening and passes through the pores in the filterelements 33, 37, while the filter elements 33, 37 are adapted to trapforeign particles therein and prevent their passage to a locationdownstream of the filter assemblies.

The filter assemblies 34, 36 may be secured to separate systemcomponents. For example, the proximal filter assembly 36 is secured tothe proximal shaft 54, while the distal filter assembly 34 is secured toguiding member 60. In FIG. 1A, the filters assemblies, 36 are secured toindependently actuatable components. This may allow the filtersassemblies, 36 to be independently positioned and controlled.Additionally, the filter assembles 34, 36 may be collapsed within twodifferent tubular members in their collapsed configurations. Forexample, the proximal filter assembly 36 is collapsed within proximalsheath 44, while the distal filter assembly 34 is collapsed withindistal sheath 58. In the system's delivery configuration, the filterassemblies 34, 36 are axially-spaced from one another. For example, inFIG. 1A, the distal filter assembly 34 is distally-spaced relative toproximal filter assembly 36. However, in an alternative embodiment, thefilter assemblies 34, 36 may be positioned such that a first filter islocated within a second filter.

In some embodiments, the distal sheath 58 and the proximal sheath 44have substantially the same outer diameter. When the filter assemblies34, 36 are collapsed within the respective sheaths 58, 44, the sheathportion of the system 30 therefore has a substantially constant outerdiameter, which can ease the delivery of the system 30 through thepatient's body and increase the safety of the delivery. The distal andproximal sheaths 58, 44 may have substantially the same outer diameter,both of which have larger outer diameters than the proximal shaft 54.The proximal shaft 54 may have a larger outer diameter than the distalshaft 56, wherein the distal shaft 56 is disposed within the proximalshaft 54. The guiding member 60 may have a smaller diameter than thedistal shaft 56. In some embodiments, the proximal and distal sheaths44, 58 have an outer diameter between 3 French (F) and 14 F. In certainembodiments, the outer diameter is between 4 F and 8 F. In still otherembodiments, the outer diameter is between 4 F and 6 F. In someembodiments, the sheaths 44, 58 have different outer diameters. Forexample, the proximal sheath 44 can have a size of 6 F, while the distalsheath 58 has a size of 5 F. In an alternate embodiment the proximalsheath 44 is 5 F and the distal sheath 58 is 4 F. These are justexamples and are not intended to limit the sheaths 44, 58 to aparticular size. A distal sheath 58 with a smaller outer diameter thanthe proximal sheath 44 reduces the delivery profile of the system 30 andcan ease delivery.

In some methods of use, the filter system 30 is advanced into thesubject through an incision made in the subject's right radial artery,or alternatively the right brachial artery. In a variety of medicalprocedures, a medical instrument is advanced through a subject's femoralartery, which is larger than the right radial artery. A deliverycatheter used in femoral artery access procedures has a larger outerdiameter than would be allowed in a filter system advanced through aradial artery. Additionally, in some uses the filter system is advancedfrom the right radial artery into the aorta via the brachiocephalictrunk. The radial artery has the smallest diameter of the vesselsthrough which the system is advanced. The radial artery therefore limitsthe size of the system that can be advanced into the subject when theradial artery is the access point. The outer diameters of the systemsdescribed herein, when advanced into the subject via a radial artery,are therefore smaller than the outer diameters of the guiding catheters(or sheaths) typically used when access is gained via a femoral artery.In some embodiments, the system 30 may be advanced over a guidewire 72,although this is not required.

The system 30 may be delivered to the left carotid artery 14 and theinnominate artery 12 in a delivery configuration. The system's deliveryconfiguration generally refers to the configuration where both filterassemblies 34, 36 are in collapsed configurations within the system(e.g., within the distal and proximal sheaths 58, 44). The distalarticulating sheath 58 may be independently movable with 3 degrees offreedom relative to the proximal sheath 44 and proximal filter assembly36. In some embodiments, the proximal sheath 44 and the distal sheath 58may be releasably coupled together. For example, the proximal sheath 44can be coupled to the distal sheath 58 using an interference fit, afriction fit, a spline fitting, end to end butt fit or any other type ofsuitable coupling between the two sheaths 44, 58. When coupled together,the components move as a unit. For example, the proximal sheath 44, theproximal shaft 54, the proximal filter assembly 36, the distal shaft 56,and the distal filter assembly 34 will rotate and translate axially (inthe proximal or distal direction) as a unit. When the proximal sheath 44is retracted to allow the proximal filter assembly 36 to expand, thedistal sheath 58 can be independently rotated, steered, or translatedaxially (either in the proximal direction or distal direction). Thedistal sheath 58 therefore has 3 independent degrees of freedom: axialtranslation, rotation, and steering. The adaptation to have 3independent degrees of freedom is advantageous when positioning thedistal sheath 58 in a target location, details of which are describedbelow.

The system 30 is advanced into the subject's right radial artery throughan incision in the right arm, or alternately through the right brachialartery. The system is advanced through the right subclavian artery 22and into the brachiocephalic or innominate artery 12, and a portion ofthe system is positioned within the aortic arch 10. The proximal sheath44 is retracted proximally to allow proximal filter support element 35to expand to an expanded configuration against the wall of theinnominate artery 12, as is shown in FIG. 1A. The proximal filterelement 37 is secured either directly or indirectly to support element35 and is therefore reconfigured to the configuration shown in FIG. 1A.The position of distal sheath 58 can be substantially maintained whileproximal sheath 44 is retracted proximally. Once expanded, the proximalfilter assembly 36 filters blood traveling through the innominate artery12, and therefore filters blood traveling into the right common carotidartery 18 and the right vertebral artery 20. The expanded proximalfilter assembly 36 is therefore in position to prevent foreign particlesfrom traveling into the right common carotid artery 18 and the rightvertebral artery 20 and into the cerebral vasculature.

The distal sheath 58 is then steered, or bent, and the distal end 70 ofthe distal sheath 58 is advanced into the left common carotid artery 14.The guiding member 60 is thereafter advanced distally relative to distalsheath 58, allowing the distal support element 31 to expand from acollapsed configuration to a deployed configuration against the wall ofthe left common carotid artery 14, as shown in FIG. 1A. The distalfilter element 33 is also reconfigured into the configuration shown inFIG. 1A. Once expanded, the distal filter assembly 34 filters bloodtraveling through the left common carotid artery 14. In someembodiments, the distal filter assembly 34 may be deployed prior to thedeployment of the proximal filter assembly 36. The distal filterassembly 34 is therefore in position to trap foreign particles andprevent them from traveling into the cerebral vasculature.

After the first filter system 30 has been positioned (or substantiallysimultaneously therewith or prior to implantation of the first system30), a second protection device or filter system 74 may be deployed, asshown in FIG. 1B. In some embodiments, the second filter system 74 maybe positioned within the aortic arch 10, although this is not required.

The protection device, or filter system, 74 comprises a proximal portion(not explicitly shown) and a distal portion 76 including a filterassembly 78. The proximal portion may be coupled to a handle (notexplicitly shown) configured to remain outside the body. In some cases,the handle of the second protection device 74 may be similar in form andfunction to the handle 40 described herein. The proximal portion isconfigured to be held and manipulated by a user such as a surgeon. Thedistal portion 76 is configured to be positioned at a target location,such as, but not limited to, the aortic arch 10. When the distal portion76 is configured to be positioned within the aortic arch 10, thelocation may be upstream of the left subclavian artery 16 such that theblood is filtered prior to entering the left subclavian artery 16 andthus prior to entering the left vertebral artery 24.

The distal portion 76 may include outer sheath 82 and an inner tubularmember 80 coupled to the filter assembly 78. The inner tubular member 80may define a lumen 84 extending from a proximal end (not explicitlyshown) to the distal end 86 thereof. The lumen 84 may be configured toreceive other medical devices, including, but not limited to anangiography or pigtail catheter 88, a procedural catheter (such as, butnot limited to a TAVR or TAVI procedural catheter or device), etc. Thepigtail catheter 88 may be radially inward of the inner tubular member80 and the inner tubular member 80 may be radially inward of the outersheath 82. The filter assembly 78 may be radially between the outersheath 82 and the pigtail catheter 88 (e.g., radially inward of theouter sheath 82 and the pigtail catheter 88 radially inward of thefilter assembly 78) in a delivery state or shape or position. While notexplicitly shown, the second protection device 74 may include a filterwire (not explicitly shown) or a guidewire radially inward of the innertubular member 80 and/or the pigtail catheter 88. The outer sheath 82and/or the inner tubular member 80 may have a diameter large enough fora procedural catheter to pass therethrough. The outer sheath 82 maycomprise an atraumatic distal tip. The protection device 74 and otherprotection devices described herein may be flexible and/or atraumatic.The outer sheath 82 may comprise a curvature, for example based on anintended placement location (e.g., the aortic arch).

The handle (not explicitly shown) can be used to translate the outersheath 82 and/or a filter assembly 78 (e.g., coupled to the innertubular member 80). For example, the handle may include a mechanism toproximally retract the outer sheath 82, distally advance the filterassembly 78 out of the outer sheath 82, or both proximally retract theouter sheath 82 and distally advance the filter assembly 78 (e.g.,simultaneously or serially), which can allow the filter assembly 78 toradially expand. The handle may also be configured to have an oppositetranslation effect, which can allow the filter assembly 78 to beradially collapsed (e.g., due to compression by the outer sheath 82) asthe filter assembly 78 is drawn into the outer sheath 82. Otherdeployment systems are also possible, for example comprising gears orother features such as helical tracks (e.g., configured to compensatefor any differential lengthening due to foreshortening of the filterassembly 78, configured to convert rotational motion into longitudinalmotion), a mechanical element, a pneumatic element, a hydraulic element,etc. for opening and/or closing the filter assembly 78.

The filter assembly 78 may include a support element or frame 90 and afilter element 92. In some embodiments, the filter assembly 78 may be astent supported filter. The frame 90 may generally provide expansionsupport to the filter element 92 in the expanded state. The frame 90 maybe similar in form and function to the frames 31, 35 described herein.Similarly, the filter element 92 may be similar in form and function tothe filter element 33 described herein. The support element 90 generallyprovides expansion support to the filter element 92 in its expandedconfigurations, while the filter element 92 is adapted to filter fluid,such as blood, and trap particles flowing therethrough. The expansionsupport 90 is adapted to engage the wall of the lumen in which it isexpanded. In some embodiments, the filter assembly 78 may beself-expanding. The filter element 92 has pores therein that are sizedto allow the blood to flow therethrough, but are small enough to preventunwanted foreign particles from passing therethrough. The foreignparticles are therefore trapped by and within the filter element 92. Itis contemplated that the filter assembly 78 may have one or moreopenings configured to allow another device (such as the pigtailcatheter 88 or a procedural catheter) to pass therethrough.

As shown in FIG. 1B, the filter assembly 78 has a generallydistally-facing opening 94. In other embodiments, the opening 94 may beproximally facing. The orientation of the opening 94 may vary dependingon where the access incision is located and/or the vessel in which it isdeployed.

The filter assembly 78 in an expanded, unconstrained state has a maximumdiameter or effective diameter (e.g., if the mouth is in the shape of anellipse) d3. The diameter d3 can be between about 1 mm and about 40 mm.In some embodiments (e.g., when the filter assembly is configured to bepositioned in the aortic arch), the diameter d3 is between about 20 mmand about 35 mm. In other embodiments (e.g., when the filter assembly isconfigured to be positioned in the left subclavian artery), the diameterd3 is between about 7 mm and about 12 mm. In yet other embodiments(e.g., when the filter assembly is configured to be positioned in theleft vertebral artery), the diameter d3 is between about 2 mm and about4.5 mm. Other diameters d3 or other types of lateral dimensions are alsopossible. Different diameters d3 can allow treatment of a selection ofsubjects having different vessel sizes.

The filter assembly 78 has a maximum length L3. The length L3 can bebetween about 7 mm and about 50 mm. Other lengths L3 are also possible,for example based on the diameter or effective diameter D3. For example,the length L3 of the filter assembly 78 may increase as the diameter D3increases, and the length L3 of the filter assembly 78 may decrease asthe diameter D3 decreases. A distance from an apex of the mouth of thefilter assembly 78 to an elbow in the frame may be about 35 mm.Different lengths L can allow treatment of a selection of subjectshaving different vessel sizes.

The distal portion 76 may include fluoroscopic markers to aid a user inpositioning the device 74, deploying the filter assembly 78, utilizingthe pigtail catheter 88, etc. A fluoroscopic marker (not explicitlyshown) may be positioned proximate to a distal end of the outer sheath82. Another fluoroscopic marker (not explicitly shown) may be positionedproximate to a proximal end of the filter assembly 78. In some cases,another fluoroscopic marker (not explicitly shown) may be proximate to adistal end of the filter assembly 78. Another fluoroscopic marker (notexplicitly shown) may be proximate to a distal end of the inner member80. The fluoroscopic markers may comprise a radiopaque material (e.g.,iridium, platinum, tantalum, gold, palladium, tungsten, tin, silver,titanium, nickel, zirconium, rhenium, bismuth, molybdenum, combinationsthereof, and the like). More or fewer fluoroscopic markers are alsopossible.

In some embodiments, the protection device 74 may include a guidewire(not explicitly shown) extending therethrough, although the guidewiremay be characterized as being separate from the protection device 74,for example independently sold, packaged, and/or directed. The guidewiremay extend through a lumen of the outer sheath 82, the inner tubularmember 80 and/or the pigtail catheter 88. The lumen of the outer sheath82, the inner tubular member 80, and/or the pigtail catheter 88 may beconfigured to receive a guidewire having a diameter between about 0.014inches (0.356 mm) and about 0.025 inches (0.635 mm). If so provided, theguidewire may extend through a lumen of the filter assembly 78. Forexample, any portion of the protection device 74 may be tracked over theguidewire to position the protection device 74 at a desired location.

The filter assembly 78 may be positioned, for example, in the aorticarch 10, to protect the cerebral vasculature (e.g., the left vertebralartery 24) from embolic debris during an endovascular procedure such asTAVI. While the procedure is described as positioning the second filterassembly 78 in the aortic arch, the method is not limited to positioningthe second filter assembly 78 within the aortic arch 10. The secondfilter assembly 78 may be positioned within other arteries (or otherlumens), as desired, such as, but not limited to the left subclavianartery 16 or the left vertebral artery 24. The filter assembly 78 may bepositioned in the aortic arch 10 upstream of the left subclavian artery16. The user may choose a protection device 74 comprising adistal-facing filter assembly 78 having a diameter appropriate for theartery (or another lumen) in which it is to be deployed. The protectiondevice 74 may be packaged in a sterile coiled packaging. The outersheath 82 may include a curvature, for example complementing the sizeand orientation of the filter assembly 78. The outer sheath 82 and/orthe inner tubular member 80 may be steerable (e.g., a pullwire-controlled sheath).

Lumens of the protection device 74, for example a lumen of the outersheath 82, a lumen of the inner member 80, and/or a lumen of the pigtailcatheter 88, may be flushed (e.g., using saline) once or several timesbefore, during, and/or after the procedure. The filter assembly 78 ofthe protection device 74 may be flushed and/or submerged (e.g., in abowl of saline). Flushing and/or submerging of the filter assembly 78may be with the filter assembly 78 in the outer sheath 82 (e.g., in thecompressed state) and/or with the filter assembly 78 out of the outersheath 82 (e.g., in the deployed state). If the filter assembly 78 isflushed and/or submerged in the deployed state, the filter assembly 78may be compressed into the outer sheath 82 before use.

The right femoral artery may be accessed using an introducer. The outersheath 82 is steered, into or towards the aortic arch 10. In some cases,the outer sheath 82 may be advanced over a guidewire, although this isnot required. In some implementations, the guidewire and the outersheath 82 and/or inner member 80 (and the filter assembly 78 coupledthereto) may be tracked together, with the guidewire leading the outersheath 82 and/or inner member 80 (e.g., advance the guidewire adistance, then advance the outer sheath 82 and/or the inner member 80over the guidewire approximately the same distance). In some cases,where the guidewire is floppy or lacks rigidity, it may be introducedinside the outer sheath 82 and then advanced ahead of the inner member80 in the vasculature. The guidewire may be advanced at least about 6centimeters (cm) distal to the distal end of the outer sheath 82 and/orinner member 80, although this is not required.

The outer sheath 82 may be curved and/or steerable to facilitatenavigation from the femoral artery to the aortic arch 10. The innertubular member 80 may be advanced simultaneously with or serially to theouter sheath 82. Additionally, the pigtail catheter 88 may be advancedsimultaneously with or serially to the inner tubular member 80 and/orthe outer sheath 82. Once the outer sheath 82 is positioned in oradjacent to the aortic arch 10, the pigtail catheter 88 may be advanceddistally from the outer sheath 80. A distal end region 96 of pigtailcatheter 88 may have a generally arcuate shape (although this is notrequired) and may include one or more apertures 98 therein. The one ormore apertures 98 may be in fluid communication with a lumen and may beconfigured to deliver a radiopaque fluid or contrast fluid.

Tracking of the protection device 74 may be performed under fluoroscopy,for example using radiopaque markers (e.g., at a distal end of the outersheath 82 and/or the inner tubular member 80) and/or radiopaque fluid orcontrast media. Radiopaque fluid may be provided through the innertubular member 80, the pigtail catheter 88, and/or the outer sheath 82.The protection device 74 may be positioned so that the filter assembly78 is upstream of the left vertebral artery 24 or proximate to theostium of the left subclavian artery 16 so that the filter assembly 78can inhibit or prevent embolic material from entering the cerebralvasculature through the left vertebral artery 24. However, it iscontemplated that positioning may be based on available anatomy.

During navigation through the vasculature, the filter assembly 78 may bedisposed within a lumen of the outer sheath 82 and held in a collapsedposition therein until the filter assembly 78 is advanced distally fromthe outer sheath 82 and/or the outer sheath 82 is proximally retractedrelative to the filter assembly 78. After the pigtail catheter 88 hasbeen deployed, the outer sheath 82 may then be proximally retracted(and/or the inner tubular member 80 distally advanced) to deploy thefilter assembly 78. In some cases, the filter assembly 78 may bedeployed before advancing the pigtail catheter 88, or substantiallysimultaneously therewith. The filter assembly 78 may be positioned todirect any dislodged debris downstream away from the left subclavianartery 16 and the left vertebral artery 24.

Once the protection device 74 is in position, the filter assembly 78 maybe deployed from the outer sheath 82. For example, the outer sheath 82may be proximally retracted and/or the filter assembly 78 may bedistally advanced. Radiopaque markers, for example on the filterassembly 78 can help determine when the filter assembly 78 achieves adeployed state. Differential longitudinal movement of the filterassembly 78 and the outer sheath 82 can cease upon full or appropriatedeployment of the filter assembly 78. Apposition of the filter assembly78 with sidewalls of the aortic arch 10 can be verified, for exampleusing radiopaque fluid or contrast media. Radiopaque fluid may beprovided through the pigtail catheter 88, the inner tubular member 80,and/or the outer sheath 82. If the radiopaque fluid is able to flowbetween the frame of the filter assembly 78 and the sidewalls of theaortic arch, then the filter assembly 78 may be improperly positioned(e.g., indicative of inadequate deployment, inadequate sizing, calcium,etc.). The filter assembly 78 may be retracted back into the outersheath 82 and redeployed, or a different protection device may be used.After positioning of the protection device 74, the pigtail catheter 88may be withdrawn and the procedural catheter advanced through the lumenof the inner tubular member 80 and the filter assembly 78. Together, thefirst protection device 30 and the second protection device 74 mayprotect all four cerebral arteries 14, 18, 20, 24 during a procedure.

The protection device(s) 30, 74 can thereafter be removed from thesubject (or at any point in the procedure). In an exemplary embodiment,the distal filter assembly 34 is first retrieved back within distalsheath 58 to the collapsed configuration. To do this, the guiding member60 is retracted proximally relative to the distal sheath 58. Thisrelative axial movement causes the distal sheath 58 to engage a strut orwire 64 and begin to move strut 64 towards guiding member 60. Thesupport element 31, which is coupled to the strut 64, begins to collapseupon the collapse of the strut 64. The filter element 33 thereforebegins to collapse as well. Continued relative axial movement betweenthe guiding member 60 and the distal sheath 58 continues to collapse thestrut 64, the support element 31, and the filter element 33 until thedistal filter assembly 34 is retrieved and re-collapsed back withindistal sheath 58 (not explicitly shown). Any foreign particles trappedwithin the distal filter element 33 are contained therein as the distalfilter assembly 34 is re-sheathed. The distal sheath 58 is then steeredinto a configuration where the distal sheath 58 is generally parallelwith the distal shaft 56. Said differently, the distal sheath 58 issteered such that it has a generally linear orientation. The proximalsheath 44 is then advanced distally relative to proximal filter assembly36. This causes proximal filter assembly 36 to collapse around thedistal shaft 56, trapping any particles within the collapsed proximalfilter element 37. The proximal sheath 44 continues to be moved distallytowards the distal sheath 58 until the proximal sheath 44 is coupledwith or nearly coupled with the distal sheath 58. The entire system 30can then be removed from the subject.

The second filter system 74 can be removed either before, substantiallysimultaneously with, or after the first filter system 30. The outersheath 82 is advanced distally relative to the filter assembly 78. Thiscauses the filter assembly 78 to collapse, trapping any particles withinthe collapsed filter element 92. The outer sheath 82 continues to bemoved distally until the entire filter assembly 78 is within the sheath82. The entire system 74 can then be removed from the subject.

In any of the embodiments mentioned herein, the filter or filterassemblies 34, 36, 78 may alternatively be detached from the deliverycatheter, and the delivery catheter removed leaving the filterassemblies 34, 36, 78 behind. The filter or filter assemblies 34, 36, 78can be left in place permanently, or retrieved by snaring it with aretrieval catheter following a post procedure treatment period of time.Alternatively, the filter assemblies 34, 36, 78 may remain attached tothe catheter, and the catheter may be left in place post procedure forthe treatment period of time. That treatment period may be at least oneday, one week, three weeks, five weeks or more, depending upon theclinical circumstances. Patients with an indwelling filter or filterassemblies may be administered any of a variety of thrombolytic oranticoagulant therapies, including tissue plasminogen activator,streptokinase, coumadin, heparin and others known in the art.

FIG. 1C illustrates an alternative embodiment for the systems of FIGS.1A and 1B. In FIG. 1C, the second protection device 100 is configured tobe positioned in the left subclavian artery 16. In the illustrativeembodiment of FIG. 1C, the first protection system 30 is deployed asdescribed above with respect to FIG. 1A. The second protection device,or filter system, 100 comprises a proximal portion (not explicitlyshown) and a distal portion 102. The proximal portion is configured tobe held and manipulated by a user such as a surgeon. In some cases, theproximal portion may be coupled to a handle configured to facilitatedelivery and deployment of the system 100. In some cases, the handle ofthe second protection device 100 may be similar in form and function tothe handle 40 described herein. The distal portion 102 is configured tobe positioned at a target location such as the left subclavian artery 16or the left vertebral artery 24. When the distal portion 102 isconfigured to be positioned at the left subclavian artery 16, thelocation may be upstream of the left vertebral artery 24 such that theblood is filter prior to entering the left vertebral artery 24.

The protection device 100 may include at least an outer sheath 104 and afilter assembly 110. The filter assembly 110 may include a supportelement or frame 112 and a filter element 114. In some embodiments, thefilter assembly 110 may be a stent supported filter. The frame 112 maybe similar in form and function to the frames 31, 35 described herein.Similarly, the filter element 114 may be similar in form and function tothe filter element 33 described herein. In some embodiments, the filterassembly 110 may be self-expanding. The support element 112 generallyprovides expansion support to the filter element 114 in its expandedconfigurations, while the filter element 114 is adapted to filter fluid,such as blood, and trap particles flowing therethrough. The expansionsupport 112 is adapted to engage the wall of the lumen in which it isexpanded. The filter element 114 has pores therein that are sized toallow the blood to flow therethrough, but are small enough to preventunwanted foreign particles from passing therethrough. The foreignparticles are therefore trapped by and within the filter element 114. Asshown in FIG. 1C, the filter assembly 110 has a generallyproximally-facing opening 116. In other embodiments, the opening 116 maybe distally facing. The orientation of the opening 116 may varydepending on where the access incision is located and/or the vessel inwhich it is deployed.

The outer sheath 104 may define a lumen 124 extending from a proximalend to the distal end 126 thereof. The lumen 124 may be configured toslidably receive the filter assembly 110, a pigtail or angiographycatheter 118, and/or a procedural catheter (such as, but not limited toa TAVR or TAVI procedural catheter or device), etc. The pigtail catheter118 and the filter assembly 110 may be radially inward of the outersheath 104. In some embodiments, the pigtail catheter 118 and the filterassembly 110 may be advanced simultaneously (or substantiallysimultaneously) through the lumen 124 of the outer sheath 104. In otherembodiments, the pigtail catheter 118 and the filter assembly 110 may beadvanced sequentially or one after the other. The filter assembly 110may be radially within the outer sheath 104 in a delivery state or shapeor position. The outer sheath 104 may have a diameter large enough for aprocedural catheter to pass therethrough. The outer sheath 104 maycomprise an atraumatic distal tip. In some cases, the outer sheath 104may be flexible and/or atraumatic. The outer sheath 104 may comprise acurvature, for example based on an intended placement location (e.g.,the left subclavian artery 16 and/or the aortic arch 10). Alternatively,or additionally, the outer sheath 104 may be steerable.

The filter assembly 110 may be coupled (e.g., crimped, welded, soldered,etc.) to a distal end of a deployment wire or filter wire 106 via astrut or wire 108. When both or all of the filter wire 106 and the strut108 are provided, the filter wire 106 and the strut 108 may be coupledwithin the outer sheath 104 proximal to the filter assembly 100 using acrimp mechanism. In other embodiments, the filter wire 106 and the strut108 may be a single unitary structure. The filter wire 106 and/or strut108 can comprise a rectangular ribbon, a round (e.g., circular,elliptical) filament, a portion of a hypotube, a braided structure(e.g., as described herein), combinations thereof, and the like. Thefilter wire 106 can be coupled to a handle or a component thereof (notexplicitly shown) to provide differential longitudinal movement relativeto the outer sheath 104, which can sheathe and unsheathe the filterassembly 110 from the outer sheath 104.

While not explicitly shown, the filter assembly 110 may, in addition to,or alternatively to, the filter wire 106, be mounted on a tubular shaft.The tubular shaft may be similar in form and function to the guidingmember 60 described above and may be advanced within the lumen 124 ofthe outer sheath 104. It is contemplated that the tubular shaft may beadvanced over a guidewire to facilitate navigation to the leftsubclavian artery 16. For example, the left subclavian artery 16 may becannulated with a guidewire and the filter assembly 110 inserted intothe left subclavian artery 16 by advancing the tubular shaft over theguidewire.

The distal portion 102 may include fluoroscopic markers to aid a user inpositioning the device 100, deploying the filter assembly 110, utilizingthe pigtail catheter 118, etc. A fluoroscopic marker (not explicitlyshown) may be positioned proximate to a distal end of the outer sheath104. Another fluoroscopic marker (not explicitly shown) may bepositioned proximate to a proximal end of the filter assembly 110. Insome cases, another fluoroscopic marker (not explicitly shown) may beproximate to a distal end of the filter assembly 110. The fluoroscopicmarkers may comprise a radiopaque material (e.g., iridium, platinum,tantalum, gold, palladium, tungsten, tin, silver, titanium, nickel,zirconium, rhenium, bismuth, molybdenum, combinations thereof, and thelike). More or fewer fluoroscopic markers are also possible.

The right femoral artery may be accessed using an introducer. The outersheath 104 is steered, into or towards the aortic arch 10. In somecases, the outer sheath 104 may be advanced over a guidewire, althoughthis is not required. In some implementations, the guidewire and theouter sheath 104, pigtail catheter 118, and/or filter assembly 110 maybe tracked together, with the guidewire leading the outer sheath 104 a(e.g., advance the guidewire a distance, then advance the outer sheath104 over the guidewire approximately the same distance). In some cases,where the guidewire is floppy or lacks rigidity, it may be introducedinside the outer sheath 104 and then advanced ahead of the filterassembly 110 in the vasculature. The guidewire may be advanced at leastabout 6 centimeters (cm) distal to the distal end of the filter assembly110, although this is not required.

The outer sheath 104 may be advanced into the descending portion of theaortic arch 10. The pigtail catheter 118 and filter assembly 110 arethen advanced through the outer sheath 104 (if they were not advancedwith the outer sheath 104). In some cases, the pigtail catheter 118 andfilter assembly 110 may be advanced together while in other cases theymay be advanced sequentially (with either the pigtail catheter 118 orthe filter assembly 110 leading). The pigtail catheter 118 may beadvanced into the ascending portion of the aortic arch 10 where it maydeliver a radiopaque fluid or contrast fluid to facilitate visualizationof the procedure. A distal end region 120 of pigtail catheter 118 mayhave a generally arcuate shape (although this is not required) andinclude one or more apertures 122 therein. The one or more apertures 122may be in fluid communication with a lumen and may be configured todeliver the radiopaque fluid or contrast fluid. As described above, thefilter assembly 110 is attached to a filter wire 106 and is advanced bythe user through manipulation of filter wire 106. By manipulating filterwire 106 coupled with optional sporadic injection of contrast mediathrough apertures 122 in the pigtail catheter 118, the user may be ableto better cannulate left subclavian artery 16 and deploy filter assembly110 therein. In some cases, the filter assembly 110 may be maintained ina delivery configuration through a radial force (e.g., by the outersheath 104 or a tubular shaft) and expand upon distal actuation. Inother embodiments, the user may exert a force on the filter assembly 110(e.g., through the filter wire 106) to deploy the filter assembly 110.Having now placed the filter assembly 110, the entire cerebralvasculature is now protected.

Tracking of the protection device 100 may be performed underfluoroscopy, for example using radiopaque markers (e.g., at a distal endof the outer sheath 104 and/or the filter assembly 110) and/orradiopaque fluid or contrast media. Radiopaque fluid may be providedthrough the pigtail catheter 118 and/or the outer sheath 104. Theprotection device 100 may be positioned so that the filter assembly 110is upstream of the left vertebral artery 24 or proximate to the ostiumof the left subclavian artery 16 so that the filter assembly 110 caninhibit or prevent embolic material from entering the cerebralvasculature through the left vertebral artery 24. However, it iscontemplated that positioning may be based on available anatomy.

During navigation through the vasculature, the filter assembly 110 maybe disposed within a lumen of the outer sheath 104 and held in acollapsed position therein until the filter assembly 110 advanceddistally from the outer sheath 104 and/or the outer sheath 104 isproximally retracted relative to the filter assembly 110. After thepigtail catheter 118 has been deployed, the outer sheath 104 may then beproximally retracted (and/or the filter wire 106 distally advanced) todeploy the filter assembly 110. In some cases, the filter assembly 110may be deployed before advancing the pigtail catheter 118, orsubstantially simultaneously therewith. The filter assembly 110 may bepositioned to direct any dislodged debris downstream away from the leftsubclavian artery 16 and the left vertebral artery 24.

Once the protection device 100 is in position, the filter assembly 110may be deployed from the outer sheath 104. For example, the outer sheath104 may be proximally retracted and/or the filter assembly 110 may bedistally advanced. Radiopaque markers, for example on the filterassembly 110 can help determine when the filter assembly 110 achieves adeployed state. Differential longitudinal movement of the filterassembly 100 and the outer sheath 104 can cease upon full or appropriatedeployment of the filter assembly 110. Apposition of the filter assembly110 with sidewalls of the left subclavian artery 16 can be verified, forexample using radiopaque fluid or contrast media. Radiopaque fluid maybe provided through the pigtail catheter 118 and/or the outer sheath104. If the radiopaque fluid is able to flow between the frame of thefilter assembly 110 and the sidewalls of the left subclavian artery 16,then the filter assembly 110 may be improperly positioned (e.g.,indicative of inadequate deployment, inadequate sizing, calcium, etc.).The filter assembly 110 may be retracted back into the outer sheath 104and redeployed, or a different protection device may be used. Afterpositioning of the protection device 100, the pigtail catheter 118 maybe withdrawn and the procedural catheter advanced through the lumen 124of the outer sheath 104. Together, the first protection device 30 andthe second protection device 100 may protect all four cerebral arteries14, 18, 20, 24 during a procedure.

The protection device(s) 30, 100 can thereafter be removed from thesubject (or at any point in the procedure). In an exemplary embodiment,the distal filter assembly 34 is first retrieved back within distalsheath 58 to the collapsed configuration. To do this, the guiding member60 is retracted proximally relative to the distal sheath 58. Thisrelative axial movement causes the distal sheath 58 to engage a strut orwire 64 and begin to move strut 64 towards guiding member 60. Thesupport element 31, which is coupled to the strut 64, begins to collapseupon the collapse of the strut 64. The filter element 33 thereforebegins to collapse as well. Continued relative axial movement betweenthe guiding member 60 and the distal sheath 58 continues to collapse thestrut 64, the support element 31, and the filter element 33 until thedistal filter assembly 34 is retrieved and re-collapsed back withindistal sheath 58 (not explicitly shown). Any foreign particles trappedwithin the distal filter element 33 are contained therein as the distalfilter assembly 34 is re-sheathed. The distal sheath 58 is then steeredinto a configuration where the distal sheath 58 is generally parallelwith the distal shaft 56. Said differently, the distal sheath 58 issteered such that it has agenerally linear orientation. The proximalsheath 44 is then advanced distally relative to proximal filter assembly36. This causes proximal filter assembly 36 to collapse around thedistal shaft 56, trapping any particles within the collapsed proximalfilter element 37. The proximal sheath 44 continues to be moved distallytowards the distal sheath 58 until the proximal sheath 44 is coupledwith or nearly coupled with the distal sheath 58. The entire system 30can then be removed from the subject.

The second filter system 100 can be removed either before, substantiallysimultaneously with, or after the first filter system 30. The outersheath 104 is advanced distally relative to the filter assembly 110.This causes the filter assembly 110 to collapse, trapping any particleswithin the collapsed filter element 114. The outer sheath 104 continuesto be moved distally until the entire filter assembly 110 is within thesheath 104. The entire system 100 can then be removed from the subject.

In any of the embodiments mentioned herein, the filter or filterassemblies 34, 36, 110 may alternatively be detached from the deliverycatheter, and the delivery catheter removed leaving the filterassemblies 34, 36, 110 behind. The filter or filter assemblies 34, 36,110 can be left in place permanently, or retrieved by snaring it with aretrieval catheter following a post procedure treatment period of time.Alternatively, the filter assemblies 34, 36, 110 may remain attached tothe catheter, and the catheter may be left in place post procedure forthe treatment period of time. That treatment period may be at least oneday, one week, three weeks, five weeks or more, depending upon theclinical circumstances. Patients with an indwelling filter or filterassemblies may be administered any of a variety of thrombolytic oranticoagulant therapies, including tissue plasminogen activator,streptokinase, coumadin, heparin and others known in the art.

FIG. 1D illustrates another alternative embodiment for the systems ofFIGS. 1A and 1B. In FIG. 1D, the second protection device 200 isconfigured to be positioned in the left subclavian artery 16. In theillustrative embodiment of FIG. 1D, the first protection system 30 isdeployed as described above with respect to FIG. 1A. The secondprotection device, or deflection system, 200 comprises a proximalportion (not explicitly shown) and a distal portion 202. The proximalportion is configured to be held and manipulated by a user such as asurgeon. In some cases, the proximal portion may be coupled to a handleconfigured to facilitate delivery and deployment of the system 200. Insome cases, the handle of the second protection device 200 may besimilar in form and function to the handle 40 described herein. Thedistal portion 202 is configured to be positioned at a target locationsuch as the left subclavian artery 16 or the left vertebral artery 24.When the distal portion 202 is configured to be positioned at the leftsubclavian artery 16, the location may be upstream of the left vertebralartery 24 such that the blood flow is blocked prior to entering the leftvertebral artery 24.

The protection device 200 may include at least an outer sheath 204 andan expandable or inflatable balloon 208. The balloon 208 may be coupledto a catheter shaft 206. The balloon 208 may be made from materialsincluding polymers such as polyethylene terephthalate (PET),polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),polybutylene terephthalate (PBT), polyurethane, polyvinylchloride (PVC),polyether-ester, polyester, polyamide, elastomeric polyamides, polyetherblock amide (PEBA), as well as other suitable materials, or mixtures,combinations, copolymers thereof, polymer/metal composites, and thelike. In some instances, the balloon 208 may include a single layer ofmaterial, whereas in other instances the balloon 208 may be of amulti-layer construction, including a plurality of layers of materials.For instance, the balloon 208 may be formed as a co-extrusion ortri-layer extrusion in some instances.

The shaft 206 may be a catheter shaft, similar to typical cathetershafts. For example, the catheter shaft 206 may include an outer tubularmember 220 and an inner tubular member 222 extending through at least aportion of the outer tubular member 220. The tubular members 220, 222may be manufactured from a number of different materials. For example,the tubular members may be made of metals, metal alloys, polymers,metal-polymer composites or any other suitable materials.

The tubular members 220, 222 may be arranged in any appropriate way. Forexample, in some embodiments the inner tubular member 222 can bedisposed coaxially within a lumen 224 of the outer tubular member 220.According to these embodiments, the inner and outer tubular members 222,220 may or may not be secured to one another along the generallongitudinal axis of the catheter shaft 206. Alternatively, the innertubular member 222 may follow the inner wall or otherwise be disposedadjacent the inner wall of the outer tubular member 220. In otherembodiments, the tubular members 220, 222 may be arranged in anotherdesired fashion.

The inner tubular member 222 may include an inner lumen 226. In at leastsome embodiments, the inner lumen 226 is a guidewire lumen for receivingthe guidewire 228 therethrough. Accordingly, the catheter 206 can beadvanced over the guidewire 228 to the desired location. The guidewirelumen 226 may extend along essentially the entire length of the cathetershaft 206 such that catheter resembles traditional “over-the-wire”catheters. Alternatively, the guidewire lumen 226 may extend along onlya portion of the catheter shaft 206 such that the catheter resembles“single-operator-exchange” or “rapid-exchange” catheters.

The catheter shaft 206 may also include an inflation lumen 224 that maybe used, for example, to transport inflation media to and from theballoon 208 to selectively inflate and/or deflate the balloon 208. Thelocation and position of the inflation lumen 224 may vary, depending onthe configuration of the tubular members 220, 222. For example, when theouter tubular member 220 surrounds the inner tubular member 222, theinflation lumen 224 may be defined within the space between the tubularmembers 220, 222. In embodiments in which the outer tubular member 220is disposed alongside the inner tubular member 222, then the inflationlumen 224 may be the lumen of the outer tubular member 220.

The balloon 208 may be coupled to the catheter shaft 206 in any of anumber of suitable ways. For example, the balloon 208 may be adhesivelyor thermally bonded to the catheter shaft 206. In some embodiments, aproximal waist of the balloon 208 may be bonded to the catheter shaft206, for example, bonded to the distal end of the outer tubular member220, and a distal waist of the balloon 208 may be bonded to the cathetershaft 206, for example, bonded to the distal end of the inner tubularmember 222. The exact bonding positions, however, may vary.

The outer sheath 204 may define a lumen 216 extending from a proximalend to the distal end 218 thereof. The lumen 216 may be configured toslidably receive the catheter 206 and balloon 208, a pigtail orangiography catheter 210, and/or a TAVR procedural catheter (or anotherprocedural catheter or device), etc. The pigtail catheter 210 and thecatheter 206 may be radially inward of the outer sheath 204. In someembodiments, the pigtail catheter 210 and the catheter 206 may beadvanced simultaneously (or substantially simultaneously) through thelumen 216 of the outer sheath 204. In other embodiments, the pigtailcatheter 210 and the catheter 206 may be advanced sequentially or oneafter the other. The catheter 206 may be radially between the outersheath 204 in a delivery state or position (e.g., with the balloon 208in a collapsed or uninflated state). The outer sheath 204 may have adiameter large enough for a procedural catheter to pass therethrough.The outer sheath 204 may comprise an atraumatic distal tip. In somecases, the outer sheath 204 may be flexible and/or atraumatic. The outersheath 204 may comprise a curvature, for example based on an intendedplacement location (e.g., the left subclavian artery 16 and/or theaortic arch 10). Alternatively, or additionally, the outer sheath 204may be steerable.

The distal portion 202 may include fluoroscopic markers to aid a user inpositioning the device 200, deploying the balloon 208, utilizing thepigtail catheter 210, etc. A fluoroscopic marker (not explicitly shown)may be positioned proximate to a distal end of the outer sheath 204.Another fluoroscopic marker (not explicitly shown) may be positionedproximate to a proximal end of the balloon 208. In some cases, anotherfluoroscopic marker (not explicitly shown) may be proximate to a distalend of the balloon 208. The fluoroscopic markers may comprise aradiopaque material (e.g., iridium, platinum, tantalum, gold, palladium,tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth,molybdenum, combinations thereof, and the like). More or fewerfluoroscopic markers are also possible.

The right femoral artery may be accessed using an introducer. The outersheath 204 is steered, into or towards the aortic arch 10. In somecases, the outer sheath 204 may be advanced over a guidewire, althoughthis is not required. In some implementations, the guidewire and theouter sheath 204, pigtail catheter 210, and/or catheter 206 may betracked together, with the guidewire leading the outer sheath 204 (e.g.,advance the guidewire a distance, then advance the outer sheath 204 overthe guidewire approximately the same distance). In some cases, where theguidewire is floppy or lacks rigidity, it may be introduced inside theouter sheath 204 and then advanced ahead of the balloon 208 in thevasculature. The guidewire may be advanced at least about 6 centimeters(cm) distal to the distal end of the balloon 208, although this is notrequired.

The outer sheath 204 may be advanced into the descending portion of theaortic arch 10. The pigtail catheter 210 and catheter 206 are thenadvanced through the outer sheath 204 (if they were not advanced withthe outer sheath 204). In some cases, the pigtail catheter 210 andcatheter 206 may be advanced together while in other cases they may beadvanced sequentially (with either the pigtail catheter 210 or thecatheter 206 leading). The pigtail catheter 210 may be advanced into theascending portion of the aortic arch 10 where it may deliver aradiopaque fluid or contrast fluid to facilitate visualization of theprocedure. A distal end region 212 of pigtail catheter 210 may have agenerally arcuate shape (although this is not required) and include oneor more apertures 214 therein. The one or more apertures 214 may be influid communication with a lumen and may be configured to deliver theradiopaque fluid or contrast fluid.

In some cases, the left subclavian artery 16 may first be cannulated bya guidewire 228, although this is not required. The catheter 206 andballoon 208 may then be advanced into the left subclavian artery 16.Once the balloon 208 is advanced into the left subclavian artery 16, theballoon 208 is inflated by injecting an inflation fluid, such as, butnot limited to, saline, saline mixed with a contrast agent, or any othersuitable fluid, through the inflation lumen 224 until the balloon 208occludes the left subclavian artery 16. This may prevent blood flowthrough the left subclavian artery 16 and thus blood flow through theleft vertebral artery 24. Having now placed the balloon 208, the entirecerebral vasculature is now protected.

Tracking of the protection device 200 may be performed underfluoroscopy, for example using radiopaque markers (e.g., at a distal endof the outer sheath 204, the catheter 206, and/or the balloon 208)and/or radiopaque fluid or contrast media. Radiopaque fluid may beprovided through the pigtail catheter 210 and/or the outer sheath 204.The protection device 200 may be positioned so that the balloon 208 isupstream of the left vertebral artery 24 or proximate to the ostium ofthe left subclavian artery 16 so that the balloon 208 can block bloodflow, and thus inhibit or prevent embolic material from entering thecerebral vasculature through the left vertebral artery 24. However, itis contemplated that positioning may be based on available anatomy.

During navigation through the vasculature, the balloon 208 may bedisposed within a lumen of the outer sheath 204 and maintained in anuninflated configuration until the balloon 208 advanced distally fromthe outer sheath 204 and/or the outer sheath 204 is proximally retractedrelative to the balloon 208. After the pigtail catheter 210 has beendeployed, the outer sheath 204 may then be proximally retracted (and/orthe catheter 206 distally advanced) to deploy the balloon 208. In somecases, the balloon 208 may be deployed before advancing the pigtailcatheter 210, or substantially simultaneously therewith.

Radiopaque markers, for example on the balloon 208 can help determinewhen the balloon 208 achieves a deployed state. Apposition of theballoon 208 with sidewalls of the left subclavian artery 16 can beverified, for example using radiopaque fluid or contrast media.Radiopaque fluid may be provided through the pigtail catheter 210 and/orthe outer sheath 204. If the radiopaque fluid is able to flow betweenthe balloon 208 and the sidewalls of the left subclavian artery 16, thenthe balloon 208 may be improperly positioned (e.g., indicative ofinadequate deployment, inadequate sizing, calcium, etc.). The balloon208 may be partially deflated and repositioned. In other embodiments,more inflation fluid may be provided to the balloon 208. Afterpositioning of the protection device 200, the pigtail catheter 210 maybe withdrawn and the procedural catheter advanced through the lumen 216of the outer sheath 204. Together, the first protection device 30 andthe second protection device 200 may protect all four cerebral arteries14, 18, 20, 24 during a procedure.

The protection device(s) 30, 200 can thereafter be removed from thesubject (or at any point in the procedure). The first protection device30 can be removed as described herein with respect to FIG. 1B. Thesecond system 200 can be removed either before, substantiallysimultaneously with, or after the first filter system 30. The inflationfluid may be removed from the balloon 208 to collapse the balloon 208.The outer sheath 204 is advanced distally relative to the balloon 208and/or the catheter 206 is proximally retracted to draw the balloon 208into the lumen 216 of the outer sheath 204. The entire system 200 canthen be removed from the subject.

FIG. 2 illustrates another illustrative protection device 300, or filtersystem to be used with the filter system 30 of FIG. 1A. In FIG. 2, thesecond protection device 300 is configured to be positioned in the leftsubclavian artery 16. In the illustrative embodiment of FIG. 2, thefirst protection system 30 is deployed as described above with respectto FIG. 1A. After the first filter system 30 has been positioned (orsubstantially simultaneously therewith or prior to implantation of thefirst system 30), a second protection device or filter system 300 may bedeployed, as shown in FIG. 2. In some embodiments, the second filtersystem 300 may be positioned within the left subclavian artery 16,although this is not required.

The protection device, or filter system, 300 comprises a proximalportion (not explicitly shown) and a distal portion 302 including afilter assembly 306. The proximal portion may be coupled to a handle(not explicitly shown) configured to remain outside the body. In somecases, the handle of the second protection device 300 may be similar inform and function to the handle 40 described herein. The proximalportion is configured to be held and manipulated by a user such as asurgeon. The distal portion 302 is configured to be positioned at atarget location such as the left subclavian artery 16. When the distalportion 302 is configured to be positioned within the aortic arch 10,the location may be upstream of the left subclavian artery 16 such thatthe blood is filtered prior to entering the left subclavian artery 16and hence the left vertebral artery 24.

The distal portion 302 may include outer sheath 304 and an inner tubularmember 312 coupled to the filter assembly 306. The inner tubular member312 may define a lumen 314 extending from a proximal end (not explicitlyshown) to the distal end 316 thereof. The lumen 314 may be configured toreceive other medical devices, including, but not limited to anangiography or pigtail catheter 318, a TAVR procedural catheter (oranother procedural catheter or device), etc. The pigtail catheter 318may be radially inward of the inner tubular member 312 and the innertubular member 312 may be radially inward of the outer sheath 304. Thefilter assembly 306 may be radially between the outer sheath 304 and thepigtail catheter 318 (e.g., radially inward of the outer sheath 304 andthe pigtail catheter 318 radially inward of the filter assembly 306) ina delivery state or position. While not explicitly shown, the secondprotection device 300 may include a filter wire (not explicitly shown)or a guidewire radially inward of the inner tubular member 312 and/orthe pigtail catheter 318. The outer sheath 304 and/or the inner tubularmember 312 may have a diameter large enough for a procedural catheter topass therethrough. The outer sheath 304 may comprise an atraumaticdistal tip. Other features of the protection device 300 and otherprotection devices described herein may be flexible and/or atraumatic.The outer sheath 304 may comprise a curvature, for example based on anintended placement location (e.g., the left subclavian artery 16).

The handle (not explicitly shown) can be used to translate the outersheath 304 and/or a filter assembly 306 (e.g., coupled to the innertubular member 312). For example, the handle may include a mechanism toproximally retract the outer sheath 304, distally advance the filterassembly 306 out of the outer sheath 304, or both proximally retract theouter sheath 304 and distally advance the filter assembly 306 (e.g.,simultaneously or serially), which can allow the filter assembly 306 toradially expand. The handle may also be configured to have an oppositetranslation effect, which can allow the filter assembly 306 to beradially collapsed (e.g., due to compression by the outer sheath 304) asthe filter assembly 306 is drawn into the outer sheath 304. Otherdeployment systems are also possible, for example comprising gears orother features such as helical tracks (e.g., configured to compensatefor any differential lengthening due to foreshortening of the filterassembly 306, configured to convert rotational motion into longitudinalmotion), a mechanical element, a pneumatic element, a hydraulic element,etc. for opening and/or closing the filter assembly 306.

The filter assembly 306 may include a support element or frame 308 and afilter element 310. In some embodiments, the filter assembly 306 may bea stent supported filter. The frame 308 may generally provide expansionsupport to the filter element 310 in the expanded state. The frame 308may be similar in form and function to the frames 31, 35 describedherein. Similarly, the filter element 310 may be similar in form andfunction to the filter elements 33, 37 described herein. The supportelement 308 generally provides expansion support to the filter element310 in its expanded configurations, while the filter element 310 isadapted to filter fluid, such as blood, and trap particles flowingtherethrough. The expansion support 308 is adapted to engage the wall ofthe lumen in which it is expanded. The filter element 310 has porestherein that are sized to allow the blood to flow therethrough, but aresmall enough to prevent unwanted foreign particles from passingtherethrough. The foreign particles are therefore trapped by and withinthe filter element 310. It is contemplated that the filter assembly 306may have one or more openings configured to allow another device (suchas the pigtail catheter 318 or a procedural catheter) to passtherethrough. In some embodiments, the filter assembly 306 and/or theinner tubular member 312 may be replaced with a balloon catheter, suchas the balloon catheter 206 described herein. It is contemplated thatthe pigtail catheter 318 may be placed through the center of the balloonthrough a lumen that is distinct from the balloon inflation lumen, orthe pigtail catheter 318 may be placed through the balloon inflationlumen that incorporates a seal with the exterior surface of the pigtailcatheter to prevent leakage of the inflation fluid.

As shown in FIG. 2, the filter assembly 306 has a generallydistally-facing opening 320. In other embodiments, the opening 320 maybe proximally facing. The orientation of the opening 320 may varydepending on where the access incision is located and/or the vessel inwhich it is deployed.

The distal portion 302 may include fluoroscopic markers to aid a user inpositioning the device 300, deploying the filter assembly 306, utilizingthe pigtail catheter 318, etc. A fluoroscopic marker (not explicitlyshown) may be positioned proximate to a distal end of the outer sheath304. Another fluoroscopic marker (not explicitly shown) may bepositioned proximate to a proximal end of the filter assembly 306. Insome cases, another fluoroscopic marker (not explicitly shown) may beproximate to a distal end of the filter assembly 306. Anotherfluoroscopic marker (not explicitly shown) may be proximate to a distalend of the inner member 312. The fluoroscopic markers may comprise aradiopaque material (e.g., iridium, platinum, tantalum, gold, palladium,tungsten, tin, silver, titanium, nickel, zirconium, rhenium, bismuth,molybdenum, combinations thereof, and the like). More or fewerfluoroscopic markers are also possible.

In some embodiments, the protection device 300 may include a guidewire(not explicitly shown) extending therethrough, although the guidewiremay be characterized as being separate from the protection device 300,for example independently sold, packaged, and/or directed. The guidewiremay extend through a lumen of the outer sheath 304, the inner tubularmember 312 and/or the pigtail catheter 318. The lumen of the outersheath 304, the inner tubular member 312 and/or the pigtail catheter 318may be configured to receive a guidewire having a diameter between about0.014 inches (0.356 mm) and about 0.025 inches (0.635 mm). If soprovided, the guidewire may extend through a lumen of the filterassembly 306. For example, any portion of the protection device 300 maybe tracked over the guidewire to position the protection device 300 at adesired location.

The filter assembly 306 may be positioned, for example, in the leftsubclavian artery 16, to protect the cerebral vasculature (e.g., theleft vertebral artery 24) from embolic debris during an endovascularprocedure such as TAVI. While the procedure is described as positioningthe second filter assembly 306 in the left subclavian artery 16, themethod is not limited to positioning the second filter assembly 306within the left subclavian artery 16. The second filter assembly 306 maybe positioned within other arteries (or other lumens), as desired, suchas, but not limited to the aortic arch 10 or the left vertebral artery24. The filter assembly 306 may be positioned in the left subclavianartery 16 upstream of the left vertebral artery 24. The user may choosea protection device 300 comprising a distal-facing filter assembly 306having a diameter appropriate for the artery (or another lumen) in whichit is to be deployed. The protection device 300 may be packaged in asterile coiled packaging. The outer sheath 304 may include a curvature,for example complementing the size and orientation of the filterassembly 306. The outer sheath 304 and/or the inner tubular member 312may be steerable (e.g., a pull wire-controlled sheath).

Lumens of the protection device 300, for example a lumen of the outersheath 304, a lumen 314 of the inner member 312, and/or a lumen of thepigtail catheter 318, may be flushed (e.g., using saline) once orseveral times before, during, and/or after the procedure. The filterassembly 306 of the protection device 300 may be flushed and/orsubmerged (e.g., in a bowl of saline). Flushing and/or submerging of thefilter assembly 306 may be with the filter assembly 306 in the outersheath 304 (e.g., in the compressed state) and/or with the filterassembly 306 out of the outer sheath 304 (e.g., in the deployed state).If the filter assembly 306 is flushed and/or submerged in the deployedstate, the filter assembly 306 may be compressed into the outer sheath304 before use.

The left brachial artery or the left radial artery may be accessed usingan introducer. The outer sheath 304 is steered, into or towards the leftsubclavian artery 16. In some cases, the outer sheath 304 may beadvanced over a guidewire, although this is not required. In someimplementations, the guidewire and the outer sheath 304 and/or filterassembly 306 may be tracked together, with the guidewire leading theouter sheath 304 and/or filter assembly 306 (e.g., advance the guidewirea distance, then advance the outer sheath 304 and/or the filter assembly306 over the guidewire approximately the same distance). In some cases,where the guidewire is floppy or lacks rigidity, it may be introducedinside the outer sheath 304 and then advanced ahead of the device 300 inthe vasculature. The guidewire may be advanced at least about 6centimeters (cm) distal to the distal end of the filter assembly 306,although this is not required.

The outer sheath 304 may be curved and/or steerable to facilitatenavigation from the femoral artery to the left subclavian artery 16. Theinner tubular member 312 may be advanced simultaneously with or seriallyto the outer sheath 304. Additionally, the pigtail catheter 318 may beadvanced simultaneously with or serially to the inner tubular member 312and/or the outer sheath 304. Once the outer sheath 304 is positioned inthe left subclavian artery 16 (distal to the ostium of the leftvertebral artery 24), the pigtail catheter 318 may be advanced distallyfrom the outer sheath 304. A distal end region 322 of pigtail catheter318 may have a generally arcuate shape (although this is not required)and may include one or more apertures 324 therein. The one or moreapertures 324 may be in fluid communication with a lumen and may beconfigured to deliver a radiopaque fluid or contrast fluid.

Tracking of the protection device 300 may be performed underfluoroscopy, for example using radiopaque markers (e.g., at a distal endof the outer sheath 304 and/or the inner tubular member 312) and/orradiopaque fluid or contrast media. Radiopaque fluid may be providedthrough the inner tubular member 312, the pigtail catheter 318, and/orthe outer sheath 304. The protection device 300 may be positioned sothat the filter assembly 306 is upstream of the left vertebral artery 24or proximate to the ostium of the left subclavian artery 16 so that thefilter assembly 306 can inhibit or prevent embolic material fromentering the cerebral vasculature through the left vertebral artery 24.However, it is contemplated that positioning may be based on availableanatomy.

During navigation through the vasculature, the filter assembly 306 maybe disposed within a lumen of the outer sheath 304 and held in acollapsed position therein until the filter assembly 306 is advanceddistally from the outer sheath 304 and/or the outer sheath 304 isproximally retracted relative to the filter assembly 306. After thepigtail catheter 318 has been deployed, the outer sheath 304 may then beproximally retracted (and/or the inner tubular member 312 distallyadvanced) to deploy the filter assembly 306. In some cases, the filterassembly 306 may be deployed before advancing the pigtail catheter 318,or substantially simultaneously therewith. The filter assembly 306 maybe positioned to capture any dislodged debris prior to entering the leftvertebral artery 24.

Once the protection device 300 is in position, the filter assembly 306may be deployed from the outer sheath 304. For example, the outer sheath304 may be proximally retracted and/or the filter assembly 306 may bedistally advanced. Radiopaque markers, for example on the filterassembly 306 can help determine when the filter assembly 306 achieves adeployed state. Differential longitudinal movement of the filterassembly 306 and the outer sheath 304 can cease upon full or appropriatedeployment of the filter assembly 306. Apposition of the filter assembly306 with sidewalls of the left subclavian artery 16 can be verified, forexample using radiopaque fluid or contrast media. Radiopaque fluid maybe provided through the pigtail catheter 318, the inner tubular member312, and/or the outer sheath 304. If the radiopaque fluid is able toflow between the frame of the filter assembly 306 and the sidewalls ofthe aortic arch, then the filter assembly 306 may be improperlypositioned (e.g., indicative of inadequate deployment, inadequatesizing, calcium, etc.). The filter assembly 306 may be retracted backinto the outer sheath 304 and redeployed, or a different protectiondevice may be used. After positioning of the protection device 300, thepigtail catheter 318 may be withdrawn and the procedural catheteradvanced through the lumen of the inner tubular member 312 and thefilter assembly 306. Together, the first protection device 30 and thesecond protection device 300 may protect all four cerebral arteries 14,18, 20, 24 during a procedure.

The protection device(s) 30, 300 can thereafter be removed from thesubject (or at any point in the procedure). The first protection device30 can be removed as described herein with respect to FIG. 1B. Thesecond filter system 300 can be removed either before, substantiallysimultaneously with, or after the first filter system 30. The outersheath 304 is advanced distally relative to the filter assembly 306.This causes the filter assembly 306 to collapse, trapping any particleswithin the collapsed filter element 310. The outer sheath 304 continuesto be moved distally until the entire filter assembly 306 is within thesheath 304. The entire system 300 can then be removed from the subject.

In any of the embodiments mentioned herein, the filter or filterassemblies 34, 36, 306 may alternatively be detached from the deliverycatheter, and the delivery catheter removed leaving the filterassemblies 34, 36, 306 behind. The filter or filter assemblies 34, 36,306 can be left in place permanently, or retrieved by snaring it with aretrieval catheter following a post procedure treatment period of time.Alternatively, the filter assemblies 34, 36, 306 may remain attached tothe catheter, and the catheter may be left in place post procedure forthe treatment period of time. That treatment period may be at least oneday, one week, three weeks, five weeks or more, depending upon theclinical circumstances. Patients with an indwelling filter or filterassemblies may be administered any of a variety of thrombolytic oranticoagulant therapies, including tissue plasminogen activator,streptokinase, coumadin, heparin and others known in the art.

FIG. 3 illustrates another illustrative protection device 400, or filtersystem in which a single filter assembly 402 is configured to protectall four cerebral arteries 14, 18, 20, 24. The filter assembly 402 mayinclude a conical filter region 404 and a deflector 406. In someembodiments, the conical filter region 404 may be configured to bepositioned with the innominate artery 12 while the deflector 406 may bepositioned over the ostia of the left common carotid artery 14 and theleft subclavian artery 16. However, other configurations are alsocontemplated. For example, the conical filter region 404 may bepositioned in the left common carotid artery 14 and the deflector 406may be positioned over the ostia of the innominate artery 12 and theleft subclavian artery 16. In another example, the conical filter region404 may be positioned in the left subclavian artery 16 and the deflector406 may be positioned over the ostia of the innominate artery 12 and theleft common carotid artery 14.

The conical filter region 404 may include an expandable frame 408 (whichmay be similar in form and function to the support members 31, 35described herein), a porous filter material 410 (which may be similar inform and function to the filter elements 33, 37 described herein), andone or more filter wires 412. In some embodiments, the filter wire 412may be coupled to a distal end 414 of the conical filter region 404,although this is not required. The filter wire 412 may be coupled to theconical filter region 404 at any location desired. As shown in FIG. 3,the conical filter region 404 has a generally proximally-facing opening434. In other embodiments, the opening 434 may be distally facing. Theorientation of the opening 434 may vary depending on where the accessincision is located and/or the vessel in which it is deployed.

The deflector 406 may include an expandable frame 418 (which may besimilar in form and function to the support members 31, 35 describedherein) and a porous filter material 420 (which may be similar in formand function to the filter elements 33, 37 described herein). It iscontemplated that the deflector 406 may not include an expandable frame418, but rather rely on the frame 408 of the conical filter region 404and/or the blood flow to position the deflector 406. For example, theexpandable frame 408 of the conical filter region 404 may act as ananchor for the deflector 406. Regardless of whether an expandable frame418 is provided, the deflector 406 may be coupled or linked to theexpandable frame 408 of the conical filter region 404.

The filter wire 412 may be used to help position and/or maintain theconical filter region 404 at the desired target location. The filterwire 412 may be configured to extend through a lumen 422 of a catheteror delivery sheath 424 to a point outside the body where the filter wire412 can be manipulated by a user. In some embodiments, the filterassembly 402 may also include one or more pull wires which may beactuated to exert a force on one or both of the frames 408, 418 to helpconform the filter assembly 402 to the upper curve of the aortic arch10. In this manner, not only are all cerebral arteries 14, 18, 20, 24protected but the filter assembly 402 may not interfere with medicaldevices, catheters, etc., being passed through the aortic arch 10.

The lumen 422 of the delivery sheath 424 may be configured to receiveother medical devices, including, but not limited to an angiography orpigtail catheter 428, a TAVR procedural catheter (or another proceduralcatheter or device), etc. The filter assembly 402 and the pigtailcatheter 428 may be radially inward of the delivery sheath 424. Thedelivery sheath 424 may have a diameter large enough for a proceduralcatheter to pass therethrough. The delivery sheath 424 may comprise anatraumatic distal tip. The protection device 400 and other protectiondevices described herein may be flexible and/or atraumatic. The deliverysheath 424 may comprise a curvature, for example based on an intendedplacement location (e.g., the innominate artery 12 and/or the aorticarch 10). While not explicitly shown, a handle may be coupled to aproximal end region of the protection system 400 and may be articulatedto facilitate deployment of the filter assembly 402 and/or navigation ofthe delivery sheath 424.

The system 400 is advanced into the subject's right femoral arterythrough an incision in the right leg. The system 400 may be advancedover or in conjunction with one or more guidewires 426. The deliverysheath 424 may be advanced through the aortic arch 10 until itcannulates the innominate artery 12. The delivery sheath 424 may becurved and/or steerable to facilitate navigation from the femoral arteryto the innominate artery 12. During navigation, the filter assembly 402may be held in a collapsed configuration within the lumen 422 of thedelivery sheath 424. When the outer sheath 424 is at or adjacent to thetarget deployment region, the outer sheath 424 may then be proximallywithdrawn to deploy the conical filter region 404. It is contemplatedthat the user may grasp a proximal end of the filter wire 412 tomaintain the conical filter region 404 in the desired configuration asthe delivery sheath 424 is withdrawn. As the delivery sheath 424 isfurther withdrawn, the deflector 406 is exposed and deployed across theostia of the left common carotid artery 14 and the left subclavianartery 16. In some embodiments, the pigtail catheter 428 could beadvanced distally of the delivery sheath 424 the aortic arch 10 prior todeploying filter assembly 402 to assist in the visualization andplacement of the filter assembly 402. For example, a distal end region430 of the pigtail catheter 428 may have a generally arcuate shape(although this is not required) and may include one or more apertures432 therein. The one or more apertures 432 may be in fluid communicationwith a lumen and may be configured to deliver a radiopaque fluid orcontrast fluid. It is further contemplated that one or more radiopaquemakers may be provided on any portion of the system 400 to facilitatevisualization.

As can be seen in FIG. 3, the protection system 400 traps (and/ordeflects) foreign particles and prevents them from traveling into thefour arteries 14, 18, 20, 24 that carry oxygenated blood to the brain.It is contemplated that when the procedure is completed, the insertionsteps may be performed in reverse to remove the system 400.

FIG. 4 illustrates another illustrative protection device 500, or filtersystem in which a single filter assembly 502 is configured to protectall four cerebral arteries 14, 18, 20, 24. The filter assembly 502 mayinclude a distal filter 504, a proximal filter 506, a deflector 508, anda filter wire 510. The distal filter 504 and the proximal filter 506 maybe linked by the deflector 508. In some embodiments, the distal filter504 may be configured to be positioned in the left subclavian artery 16,the proximal filter 506 may be configured to be positioned in theinnominate artery 12, and the deflector 508 may be positioned across theostium of the left common carotid artery 14. However, otherconfigurations are also contemplated. In other instances, the distalfilter 504 may be positioned in the left common carotid artery 14, theproximal filter 506 may positioned in the innominate artery 12, and thedeflector 508 over the ostium of the left subclavian artery 16. Inanother example, the distal filter 504 may be positioned in the leftsubclavian artery 16, the proximal filter 506 may positioned in the leftcommon carotid artery 14, and the deflector 508 over the ostium of theinnominate artery 12.

The distal filter 504 may include an expandable frame 512 (which may besimilar in form and function to the support members 31, 35 describedherein), a porous filter material 514 (which may be similar in form andfunction to the filter elements 33, 37 described herein), and one ormore filter wires 510. In some embodiments, the filter wire 510 may becoupled to a distal end 516 of the distal filter 504, although this isnot required. The filter wire 510 may be coupled to the distal filter504 at any location desired. As shown in FIG. 4, the distal filter 504has a generally proximally-facing opening 518. In other embodiments, theopening 518 may be distally facing. The orientation of the opening 518may vary depending on where the access incision is located and/or thevessel in which it is deployed.

The proximal filter 506 may include an expandable frame 520 (which maybe similar in form and function to the support members 31, 35 describedherein), a porous filter material 522 (which may be similar in form andfunction to the filter elements 33, 37 described herein), and one ormore filter wires 510. In some embodiments, the filter wire 510 may notbe coupled to the proximal filter 506, while in other embodiments, thefilter wire 510 may be coupled to the proximal filter 506 at anylocation desired. As shown in FIG. 4, proximal filter 506 has agenerally distally-facing opening 524. In other embodiments, the opening524 may be proximally facing. The orientation of the opening 518 mayvary depending on where the access incision is located and/or the vesselin which it is deployed.

The deflector 508 may include a porous filter material 526 (which may besimilar in form and function to the filter elements 33, 37 describedherein). The filter material 526 may be coupled to and extend betweenthe distal filter 504 and the proximal filter 506. It is contemplatedthat the positioning of the distal filter 504 and the proximal filter506 may position the deflector 508 over the ostium of the left commoncarotid artery 14. However, the deflector 508 may be provided with anexpandable frame (not explicitly shown) to facilitate positioning and/ordeployment of the deflector 508.

The filter wire 510 may be used to help position and/or maintain thedistal filter 504 at the desired target location. The filter wire 510may be configured to extend through a lumen 528 of a catheter ordelivery sheath 530 to a point outside the body where the filter wire510 can be manipulated by a user. In some embodiments, the filterassembly 502 may also include one or more pull wires which may beactuated to exert a force on one or both of the frames 512, 520 to helpposition and/or conform the filter assembly 502 to the upper curve ofthe aortic arch 10. In this manner, not only are all cerebral arteries14, 18, 20, 24 protected but the filter assembly 502 may not interferewith medical devices, catheters, etc., being passed through the aorticarch 10.

The lumen 528 of the delivery sheath 530 may be configured to receiveother medical devices, including, but not limited to an angiography orpigtail catheter, a TAVR procedural catheter (or another proceduralcatheter or device), etc. The entire filter assembly 502 (e.g., thedistal filter 504, proximal filter 506, deflector 508, and filter wire510) may be loaded within the delivery sheath 530 for delivery to thetarget location. In some embodiments, the delivery sheath 530 may have adiameter large enough for a procedural catheter to pass therethrough,although this is not required. The delivery sheath 530 may comprise anatraumatic distal tip. The protection device 500 and other protectiondevices described herein may be flexible and/or atraumatic. The deliverysheath 530 may comprise a curvature, for example based on an intendedplacement location (e.g., the innominate artery 12 and/or the leftsubclavian artery 16). While not explicitly shown, a handle may becoupled to a proximal end region of the protection system 500 and may bearticulated to facilitate deployment of the filter assembly 502 and/ornavigation of the delivery sheath 530.

The system 500 is advanced into and through the subject's right radialartery or right brachial artery. The system 500 may be advanced over orin conjunction with one or more guidewires 532. The delivery sheath 530may be advanced through the innominate artery 12 and into the aorticarch 10. The delivery sheath 530 may be further advanced to cannulatethe left subclavian artery 16. The delivery sheath 530 may be curvedand/or steerable to facilitate navigation from the right radial arteryor right brachial artery to the left subclavian artery 16. Duringnavigation, the filter assembly 502 may be held in a collapsedconfiguration within the lumen 528 of the delivery sheath 530. When theouter sheath 530 is at or adjacent to the target deployment region, theouter sheath 530 may then be proximally withdrawn to deploy the distalfilter 504 in the left subclavian artery 16. It is contemplated that theuser may grasp a proximal end of the filter wire 510 to maintain thedistal filter 504 in the desired configuration as the delivery sheath530 is withdrawn. As the delivery sheath 530 is further withdrawn, thedeflector 508 is exposed and deployed across the ostia of the leftcommon carotid artery 14. Continued proximal retraction of the deliverysheath 530 deploys the proximal filter 506 in the innominate artery 12.

As can be seen in FIG. 4, the protection system 500 traps (and/ordeflects) foreign particles and prevents them from traveling into thefour arteries 14, 18, 20, 24 that carry oxygenated blood to the brain.It is contemplated that when the procedure is completed, the insertionsteps may be performed in reverse to remove the system 500.

FIG. 5 illustrates another illustrative protection device, or filtersystem, 600 in which three filters are delivered with a single deliverydevice. The filter system 600 may include a distal end region 602including at least a first filter assembly 604, a second filter assembly606, and a third filter assembly 608 and a proximal end region (notexplicitly shown) coupled to a handle (not explicitly shown) configuredto remain outside the body. The first filter assembly 604, second filterassembly 606, and third filter assembly 608 may each include a supportmember or frame 610, 612, 614 and a filter element 616, 618, 620. Thesupport members 610, 612, 614 may be similar in form and function to thesupport members 31, 35 described herein. The filter elements 616, 618,620 may be similar in form and function to the filter elements 33, 37described herein. In some cases, the handle of the filter system 600 maybe similar in form and function to the handle 40 described herein.

The distal end region 602 may include a proximal sheath 622, a proximalshaft (not explicitly shown) similar in form and function to theproximal shaft 54 described with respect to FIG. 1A coupled to theexpandable proximal, or third, filter assembly 608, a distal shaft (notexplicitly shown) similar in form and function to the distal shaft 56described with respect to FIG. 1A coupled to a distal articulatablesheath 624, the intermediate, or second, filter assembly 606, thedistal, or first filter assembly 604, and a guiding member (notexplicitly shown). In the filter system 600 illustrated in FIG. 5, boththe first filter assembly 604 and the second filter assembly 606 may beloaded into the distal sheath 624 for delivery while the third filterassembly is loaded into the proximal sheath 622 for delivery. The firstand second filter assemblies 604, 606 may be coupled together via a wireor tether 626. In some cases, the tether 626 may be made having apredetermined shape to better assist the tether 626 in seating andspanning the distance from the ostium of the left subclavian artery 16to the left common carotid artery 14.

The system 600 is advanced into the subject's right radial arterythrough an incision in the right arm, or alternatively through the rightbrachial artery. While not explicitly shown, the system 600 may beadvanced over or in conjunction with one or more guidewires. The systemis advanced through the right subclavian artery 22 and into theinnominate artery 12, and a portion of the system is positioned withinaortic arch 10. The proximal sheath 622 is retracted proximally to allowproximal filter support element 614 to expand to an expandedconfiguration against the wall of the innominate artery 12, as is shownin FIG. 5. The proximal filter element 620 is secured either directly orindirectly to support element 614 and is therefore reconfigured to theconfiguration shown in FIG. 5. The position of distal sheath 624 can besubstantially maintained while proximal sheath is retracted proximally.Once expanded, the proximal filter assembly 608 filters blood travelingthrough the innominate artery 12, and therefore filters blood travelinginto the right common carotid artery 18 and the right vertebral artery20. The expanded proximal filter assembly 608 is therefore in positionto prevent foreign particles from traveling into the right commoncarotid artery 18 and the right vertebral artery 20 and into thecerebral vasculature.

The distal sheath 624 is then steered, or bent, and the distal end ofthe distal sheath 624 is advanced into the left subclavian artery 16.The guiding member (not explicitly shown) is thereafter advanceddistally relative to distal sheath 624, allowing the distal supportelement 610 to expand from a collapsed configuration to a deployedconfiguration against the wall of the left subclavian artery 16, asshown in FIG. 5. Alternatively, or additionally, the distal sheath 624may be proximally retracted to deploy the distal filter assembly 604.The distal filter element 616 is also reconfigured into theconfiguration shown in FIG. 5. Once expanded, the distal filter assembly604 filters blood traveling through the left subclavian artery 16. Theexpanded distal filter assembly 604 is therefore in positioned toprevent foreign particles from traveling into the left subclavian artery16 and the left vertebral artery 24 and into the cerebral vasculature.

Once the distal filter assembly 604 has been positioned in the leftsubclavian artery, the tether 626 may be distally advanced to provideadditional length or “slack” to allow the distal sheath 624 to berepositioned. In some embodiments, the tether 626 may pass through aneyelet 628 which is coupled to the second filter 606. The distal sheath624 may be manipulated to then cannulate the left common carotid artery14. The guiding member (not explicitly shown) is thereafter advanceddistally relative to distal sheath 624, allowing the intermediatesupport element 612 to expand from a collapsed configuration to adeployed configuration against the wall of the left common carotidartery 14, as shown in FIG. 5. The intermediate filter element 618 isalso reconfigured into the configuration shown in FIG. 5. Once expanded,the intermediate filter assembly 606 filters blood traveling through theleft common carotid artery 14. In some embodiments, the distal filterassembly 604 and the intermediate filter assembly 606 may be deployedprior to the deployment of the proximal filter assembly 608. Theintermediate filter assembly 606 is therefore in position to trapforeign particles and prevent them from traveling into the cerebralvasculature. As can be seen in FIG. 5, the protection system 600 trapsforeign particles and prevent them from traveling into the four arteries14, 18, 20, 24 that carry oxygenated blood to the brain. It iscontemplated that when the procedure is completed, the insertion stepsmay be performed in reverse to remove the system 600.

While the methods and devices described herein may be susceptible tovarious modifications and alternative forms, specific examples thereofhave been shown in the drawings and are described in detail herein. Itshould be understood, however, that the inventive subject matter is notto be limited to the particular forms or methods disclosed, but, to thecontrary, covers all modifications, equivalents, and alternativesfalling within the spirit and scope of the various implementationsdescribed and the appended claims. Further, the disclosure herein of anyparticular feature, aspect, method, property, characteristic, quality,attribute, element, or the like in connection with an implementation orembodiment can be used in all other implementations or embodiments setforth herein. In any methods disclosed herein, the acts or operationscan be performed in any suitable sequence and are not necessarilylimited to any particular disclosed sequence and not be performed in theorder recited. Various operations can be described as multiple discreteoperations in turn, in a manner that can be helpful in understandingcertain embodiments; however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures described herein can be embodied asintegrated components or as separate components. For purposes ofcomparing various embodiments, certain aspects and advantages of theseembodiments are described. Not necessarily all such aspects oradvantages are achieved by any particular embodiment. Thus, for example,embodiments can be carried out in a manner that achieves or optimizesone advantage or group of advantages without necessarily achieving otheradvantages or groups of advantages. The methods disclosed herein mayinclude certain actions taken by a practitioner; however, the methodscan also include any third-party instruction of those actions, eitherexpressly or by implication. For example, actions such as “deploying aself-expanding filter” include “instructing deployment of aself-expanding filter.” The ranges disclosed herein also encompass anyand all overlap, sub-ranges, and combinations thereof. Language such as“up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“about” or “approximately” include the recited numbers and should beinterpreted based on the circumstances (e.g., as accurate as reasonablypossible under the circumstances, for example ±5%, ±10%, ±15%, etc.).For example, “about 7 mm” includes “7 mm.” Phrases preceded by a termsuch as “substantially” include the recited phrase and should beinterpreted based on the circumstances (e.g., as much as reasonablypossible under the circumstances). For example, “substantially straight”includes “straight.”

Those skilled in the art will recognize that the present invention maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departure in form anddetail may be made without departing from the scope and spirit of thepresent invention as described in the appended claims.

What is claimed:
 1. A method of inhibiting embolic material fromentering cerebral vasculature, the method comprising: positioning aguidewire through a right subclavian artery and into a left commoncarotid artery; tracking a distal portion of a first protection deviceover the guidewire, the distal portion of the first protection devicecomprising: a proximal sheath; a proximal self-expanding filter assemblyradially within the proximal sheath; a distal sheath; and a distalself-expanding filter assembly radially within the distal sheath; atleast one of proximally retracting the proximal sheath and distallyadvancing the proximal self-expanding filter assembly to deploy theproximal self-expanding filter assembly from the proximal sheath in theinnominate artery; steering the distal sheath into a left common carotidartery; at least one of proximally retracting the distal sheath anddistally advancing the distal self-expanding filter assembly to deploythe distal self-expanding filter assembly from the distal sheath in theleft common carotid artery; after deploying the proximal and distalself-expanding filter assemblies, withdrawing the proximal and distalsheaths; tracking a distal portion of a second protection device from anincision in a femoral artery to an aortic arch, the distal portion ofthe second protection device comprising: an outer sheath; an innertubular member radially within the outer sheath; and a self-expandingfilter assembly radially within the outer sheath and coupled to theinner tubular member; and at least one of proximally retracting theouter sheath and distally advancing the inner tubular member to deploythe self-expanding filter assembly from the outer sheath.
 2. The methodof claim 1, wherein an opening of the self-expanding filter assembly ofthe second protection device is positioned in the aortic arch upstreamof an ostium of a left subclavian artery.
 3. The method of claim 2,wherein the opening is a distally facing opening.
 4. The method of claim1, wherein the second protection device further comprises a pigtailcatheter radially inward of the inner tubular member.
 5. The method ofclaim 4, wherein after deploying the self-expanding filter assembly ofthe second protection device, withdrawing the pigtail catheter.
 6. Themethod of claim 1, further comprising performing an endovascularprocedure, the deployed proximal and distal filter assemblies of thefirst protection device and the self-expanding filter assembly of thesecond protection device inhibiting embolic material from enteringcerebral vasculature through the left vertebral artery, a right commoncarotid artery, a right vertebral artery and the left common carotidartery during the endovascular procedure.
 7. The method of claim 6,further comprising after performing the endovascular procedure,withdrawing the proximal and distal filter assemblies of the firstprotection device and the self-expanding filter assembly of the secondprotection device.
 8. The method of claim 6, wherein a proceduralcatheter for performing the endovascular procedure is advanced through alumen of the inner tubular member of the second protection device. 9.The method of claim 1, wherein an opening of the self-expanding filterassembly of the second protection device is positioned in a leftsubclavian artery upstream of an ostium of a left vertebral artery. 10.The method of claim 9, wherein the opening is a proximally facingopening.